Careers

Are you someone who wants to improve surgical outcomes for patients? We’re seeking problem solvers, creative thinkers, tinkerers, inventors and others who really want to make a difference. We’re focused on the design and development of surgical technologies for application in robotic single access surgery. We’re a publicly-held Canadian company headquartered in Toronto. We’re listed on the Toronto Stock Exchange (TMD) and Nasdaq (TMDI). Our research and development operations are based in Chapel Hill, North Carolina. Come join our growing team!

Mechanical Designer & MCAD Administrator

May 27, 2021

Position Summary:

This position is responsible for assisting in the development, documentation, and release of individual assigned components/subsystems within Titan Medical’s surgical robotic system. This person must be able to apply design for manufacturing fundamentals to assess design decisions. Experience working on complex systems and medical devices or products with similar regulatory environments is preferred. Must be able to lead and review mechanical design & development activities. Additionally, this position will include MCAD administration activities related to the management of the SOLIDWORKS PDM system.

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Design/Drafting Responsibilities and Duties:

  • Design, build, and validate new and existing products
  • Create, evaluate, and release design documentation such as 3D models and 2D drawings using a PDM and PLM system
  • Participate in design and drawing reviews
  • Design, fabricate, assemble, and validate assembly/test fixtures for production of new and existing products
  • Manage and maintain device drawing package and BOM
  • Support research initiatives

 

MCAD Administrator Responsibilities and Duties:

  • Manage PDM Vault
  • Ensure effective communication and processes between PDM & PLM systems
  • Develop, implement and monitor MCAD design standards and procedures to meet quality & regulatory needs
  • Identify opportunities and recommendations for increasing workflow efficiencies
  • Troubleshoot system and process failures
  • Train and supervise MCAD users in core application skills and standards
  • Provide guidance and direction to engineering team to ensure operational and technical excellence

 

Other Responsibilities:

  • Support use of robotic surgical system in preclinical and clinical environments
  • Provide technical support/consulting to Titan Medical staff and contract development and manufacturing entities
  • Identify and resolve quality issues
  • Support regulatory filings
  • Perform other duties as assigned

 

Education/Experience:

  • Associates degree in CAD, engineering, or a related field
  • 4 years of design & drafting experience
  • Familiarity with manufacturing processes is required
  • SOLDIWORKS software experience is required
  • Prior medical or ISO 9001 device experience is preferred
  • Experience with hand fabrication/electromechanical assembly is desirable
  • Robotics experience is desirable

 

Qualifications:

  • Self-motivated, proactive, and independent, with strong organizational skills to handle shifting priorities, multiple projects/tasks with minimal supervision
  • Demonstrates logical thinking with exceptional problem solving skills
  • Strong computing skills including MS Office Suite, MS Project or equivalent
  • Good organizational, planning and time management skills

 

Work Environment and Physical Demands:

  • Duties will be split between office environment, laboratory, and manufacturing facilities
  • Standing or sitting for long periods may be required
  • Overtime may be necessary as workloads dictate. This may include weekdays, weekends and/or holidays to meet project deadlines
  • Able to move and lift equipment and supplies up to 70 pounds without mechanical aid
  • Ability to see computer terminal and electronic displays on devices (with or without prescription glasses)

Hardware and Software Quality
Engineering Lead

February 1, 2021

Position Summary:

This individual shall develop and oversee testing strategies for both software and hardware for Titan Medical’s surgical robotic system. A key requirement of this position will be to ensure an elevated level of coordination between hardware and software testing resulting in high efficiency execution and the release of a high-quality product at commercialization.  This includes assisting with the development of integration tests and system tests, both automated and manual. This individual will help determine appropriate test methods and tools. This individual will participate in software and hardware design reviews and test reviews ensuring hardware and software testing alignment.

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Product Development Responsibilities:

  • Develop a unified testing strategy that accounts for both hardware and software
  • Deliver the appropriate Design History File (DHF) artifacts to include, but not limited to: Test Plan, Regression/Impact Analysis, Product Compatibility Matrix, Verification and Validation Report, etc
  • Lead Tool Validation efforts as needed
  • Establish KPIs in Jama and establish visibility through Jama Dashboard widgets
  • Review software and hardware requirements and design to develop tests for product software
  • Establish Jama Test Cycles for hardware and software and monitor through to completion
  • Design and implement both automated and manual tests to verify correct performance of product software
  • Generate detailed test reports and summary test reports from Jama and other tools
  • Participate in design and test reviews. Thoroughly assess the ability of proposed tests to meet specified requirements.
  • Conform to the standards for the design and testing of medical device software and hardware

Administrative Responsibilities and Duties:

  • Provide input to Quality Manager and management on progress of projects
  • Provide input for schedules
  • Provide leadership for the software and hardware test engineers
  • Manage day to day tasks and ensure efficient resource engagement and execution

Education/Experience:

  • S. in Computer Engineering, Computer Science, or Electrical Engineering or similar.
  • 5+ years of demonstrated experience developing testing strategies for embedded software systems and hardware is required, medical devices preferred
  • Prefer experience managing test engineering projects

Qualifications:

  • Experience developing tests and testing strategies for embedded software and hardware
  • Experience creating and setting up Jama test cycles, monitoring and closing. Jama test execution dashboard set up.
  • Prefer experience with IEC 62304, ISO 14971, and FDA guidance on medical devices
  • Strong communication skills with the ability to interact effectively with people at all levels of the organization

 

Work Environment and Physical Demands:

  • Duties will be split between office environment and laboratory
  • Overtime may be necessary as workloads dictate. This may include weekdays, weekends and/or holidays to meet project deadlines
  • Standing or sitting for long periods may be required
  • Ability to see computer terminal and electronic displays on devices (with or without prescription glasses)

 

Titan Medical is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of this position.

 

Recruiting Agencies, Please Note:

Titan Medical will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Titan Medical via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Titan Medical. No fee will be paid in the event the candidate is hired by Titan Medical as a result of the referral or through other means.

 

Business Systems Engineer

February 1, 2021

Position Summary:

This position will include performing detailed requirements analysis, documenting findings, working with stakeholders and acting in the capacity of a customer advocate/representative for the Titan Medical R&D team.  Experience with complex and regulated medical devices is highly desirable for this role.

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Responsibilities and Duties:

  • Evaluating requirements, business processes, anticipating requirements, uncovering areas for improvement.
  • Leading reviews of previously established requirements, ensuring alignment to User Needs and Business Goals.
  • Staying up to date on the latest FDA/Regulatory changes related to medical devices and leveraging that information as needed.
  • Conducting meetings and presentations to share ideas and findings.
  • Own the creation of Design History File (DHF) outputs such as, but not limited to: Product Requirements Specification, Traceability Matrix, Release Notes, Risk Assessment, etc.
  • Actively maintaining Requirements in the Requirements Management Tool to ensure traceability and appropriate coverage
  • Highly effective communication skills.
  • Gathering critical information from meetings with various stakeholders.
  • Working closely with clients, technicians, and managerial staff.
  • Ensuring solutions meet business and customer needs and requirements.
  • Performing user acceptance testing and acting as a customer/user advocate
  • Prioritizing initiatives based on business needs and requirements.
  • Serving as a liaison between stakeholders and users.
  • Managing competing resources and priorities.
  • Work with development and testing to ensure requirements alignment and understanding
  • Monitoring deliverables and ensuring timely completion of initiatives.

 

Education/Experience:

 

  • Minimum of a Bachelor’s of Science degree in Computer Engineering, or equivalent
  • 3-5+ years of experience in a medical device industry is preferred.
  • 3-5+ years of experience as an analyst is required.
  • Exceptional analytical and conceptual thinking skills.
  • The ability to influence stakeholders and work closely with them to determine acceptable solutions.
  • In-depth knowledge of IEC 62304 and ISO 14971preferred
  • Advanced technical skills.
  • Excellent documentation skills.
  • Competency in Microsoft applications including Word, Excel, and Outlook.
  • A track record of following through on commitments.
  • Self-motivated, proactive, and independent, with strong organizational skills to handle shifting priorities, multiple projects/tasks with minimal supervision
  • Logical thinking with exceptional problem-solving skills
  • Ability to rapidly comprehend device operation in laboratory and clinical settings
  • Clinical background preferred.
  • Working knowledge of manufacturing processes related to medical device manufacturing preferred.
  • 3+ years of experience with Jama (Requirements, traceability, dashboards) required.
  • Arena PLM experience preferred
  • Ability to prioritize and work independently as a self-starter with strong proactive work ethic.
  • Familiar with FDA documentation requirements, QSR, and Good Manufacturing Practices preferred.

 

Titan Medical is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of this position.

 

Recruiting Agencies, Please Note:

Titan Medical will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Titan Medical via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Titan Medical. No fee will be paid in the event the candidate is hired by Titan Medical as a result of the referral or through other means.

 

Hardware Verification & Validation Engineer

February 1, 2021

Position Summary:

The hardware verification and validation engineer contributes to the delivery of verification services to complex firmware / embedded software application and hardware products. This role works with the engineering team to deliver the verification service in accordance with our defined quality system. Ensure that products are tested in adherence to the applicable regulation (FDA/ISO13485) and best practices.

Responsibilities include implementing/driving the V&V on hardware components of a project, as well as developing strong partnerships with other technical resources (PM, Engineers, Systems and Support resources). This position is responsible for ensuring all V&V project deliverables adhere to the Titan Medical Quality System and related standards.

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Product Development Responsibilities:

  • V&V service life cycle; plan, realize, deliver, and own
  • Participate with establishing standards on Design Verification and Validation (V&V) processes and tools.
  • Responsible for DHF deliverables including, but not limited to Test Plan/Strategy, Regression Analysis, Test Report, etc.
  • Participate and provide feedback within the Risk Management reviews
  • Influences engineers and project team to follow the defined procedures within the quality system
  • Contributes to the acquisition or implementation of improved QE techniques and tools
  • Use quantitative estimating techniques base on industry practice and personal experience
  • Uses metrics to collect quantitative project data
  • Develop an in-depth understanding of assigned hardware, and solutions
  • Contributes to product design for compliance with functional and technical specifications as well as customer satisfaction
  • Applies ingenuity and determination to find the best possible options to support business needs
  • Contributes to the development of the hardware quality strategy and provides to Testing Lead
  • Creates test strategies that increase test coverage, validate scalability, failover and recovers and improves quality
  • Defines and documents test cases to exercise the product to reveal potential defects
  • Supports environmental testing, Standards testing and usability testing
  • Maintains real time log of executed tests, results, and environment
  • Designs, implements and validate automated tests and test harnesses/rigs used for formal execution

Administrative Responsibilities and Duties:

  • Provide input to Quality Manager and management on progress of projects
  • Provide input for schedules
  • Manage day to day tasks and ensure efficient resource engagement and execution

Education/Experience:

  • B.S. in Biomedical Engineering, Mechanical Engineering, Electrical Engineering or similar.
  • 5+ years of demonstrated experience developing testing strategies for embedded software systems and hardware is required, medical devices preferred
  • 2+ years requirements development and management experience in Jama required

Qualifications:

  • Experience developing tests and testing strategies for hardware
  • Experience creating and setting up Jama test cycles, monitoring and closing. Jama test execution dashboard set up.
  • Prefer experience with IEC 62304, ISO 14971, and FDA guidance on medical devices
  • Strong communication skills with the ability to interact effectively with people at all levels of the organization

 

Work Environment and Physical Demands:

  • Duties will be split between office environment and laboratory
  • Overtime may be necessary as workloads dictate. This may include weekdays, weekends and/or holidays to meet project deadlines
  • Standing or sitting for long periods may be required
  • Ability to see computer terminal and electronic displays on devices (with or without prescription glasses)

 

Titan Medical is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of this position.

 

Recruiting Agencies, Please Note:

Titan Medical will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Titan Medical via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Titan Medical. No fee will be paid in the event the candidate is hired by Titan Medical as a result of the referral or through other means.

 

Electrical Engineering Tech – Chapel Hill

January 21, 2021

Position Summary:

The electrical engineering technician is responsible for providing technical and development support for Titan Medical’s robotic surgical platform at all stages of development including design, prototyping, engineering validation, design validation, regulatory verification/validation, manufacturing, sustaining engineering, and end-of-life. The Titan robotic surgical platform is a complex collection of interoperating electrical, mechanical, and software systems.  Because of this, the role of the technician is defined by an exciting diversity of tasks including design support, prototype assembly/test, documentation, design/fabrication/use of jigs and fixtures, and work with regulatory agencies for verification, validation and test activities. 

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Responsibilities and Duties:

  • Provide diverse, comprehensive technical support for assembly, test, and operation of robotic surgical systems and subsystems
  • Manage the EE laboratory. Maintaining a clean, properly stocked work environment for engineering prototyping
  • Make and execute purchasing decisions for equipment, tools and supplies needed for electrical and electromechanical prototyping, test and service
  • Ensure appropriate selection and qualification of vendors and contract service providers.
  • Participate in engineering design review and DFM activities
  • Document a variety of electrical and electromechanical assembly and test procedures
  • Perform engineering qualification of new designs (board bring-up, cable harness verification, etc)
  • Design, construct and operate jigs and test fixtures for assembly and test of electrical and electromechanical subsystems
  • Collect, summarize, and present test data. Provide recommendations for improvement to electrical and electromechanical designs based on test results.
  • Perform incoming quality inspection and documentation for components and subsystems provided by external contractors.
  • Support the use of robotic surgical systems in preclinical and clinical environments.
  • Provide documentary support for regulatory filings.
  • Determine if outside services can be used cost effectively and expeditiously in place of in-house resources, and coordinate the use of these services as appropriate. .

 

Education/Experience:

  • 8 years or greater experience in electrical/electromechanical engineering/technician role required
  • Completion of technology degree/certificate program is encouraged
  • IPC electronics workforce certifications encouraged

 

Experience/Skills:

The ideal candidate would have experience or skills in some or all of the following areas

  • Soldering and rework, particularly for small packages (DFN/QFN/BGA)
  • Prototyping, assembly, and test of cable harnesses
  • Machine shop skills: Comfort using basic hand and machine tools including mill, lathe, laser cutter, etc.
  • Strong written communication skills and experience with office suite software including word, excel, powerpoint or equivalent
  • EDA/CAD software and formats. Ability to use EDA tools to inspect electrical design data. (eg. Gerber data, ODB++ databases, etc)
  • Reading and marking up electrical schematics and wiring diagrams
  • Communicating with regulatory agencies (UL, TUV, etc) about test results, test schedule, etc.
  • Use of test and diagnostic equipment such as oscilloscopes, multimeters, source measure units, hi-pot testers, etc.
  • Programming or system design software such as Python, MATLAB, LabView or similar
  • Diagramming with software such as Visio or similar
  • Board bring-up and subsystem testing on PCBAs
  • PLC programming/troubleshooting
  • Flashing and verifying firmware on PCBAs/SoM systems
  • Inventory management using spreadsheets or basic inventory management software
  • Strong analytical/problem solving skills

 

Qualifications:

  • Self-motivated, proactive, and independent, with strong organizational skills to handle shifting priorities, multiple projects/tasks with minimal supervision.
  • Able to travel 10%-20% for manufacturing audits and to support clinical trial sites if needed.

 

Work Environment and Physical Demands:

  • Duties will be split between office environment, laboratory.
  • Overtime may be necessary as workloads dictate. This may include weekdays, weekends and/or holidays to meet project deadlines.
  • Travel will be required outside of the area to varying locations and environments with little notice.
  • Able to move and lift equipment and supplies up to 70 pounds without mechanical aid.
  • Standing or sitting for long periods may be required.
  • Ability to see computer terminal and electronic displays on devices (with or without prescription glasses).

 

 

Titan Medical is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of this position.

 

Recruiting Agencies, Please Note:

Titan Medical will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Titan Medical via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Titan Medical. No fee will be paid in the event the candidate is hired by Titan Medical as a result of the referral or through other means.

 

 

 

 

 

 

 

 

 

 

Mechanical Engineer – Chapel Hill

January 21, 2021

Position Summary:

This position is responsible for assisting in the development of individual assigned subsystems and requirements within Titan Medical’s surgical robotic system. This person must be able to apply engineering fundamentals to assess design decisions and to execute effective designs. Experience working on complex systems and medical devices or products with similar regulatory environments will be key. Must be able to plan, lead, and review mechanical subsystem development programs and activities, and identify issues while ensuring success. A demonstrated portfolio of design work is essential. This individual is elf-motivated, proactive, and independent, with strong organizational skills to handle shifting priorities and multiple projects/tasks with minimal supervision.

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Design Engineering Responsibilities and Duties:

  • Translate Company needs into engineering requirements.
  • Design, build, and validate new and existing products.
  • Create, evaluate, and release design documentation such as 3D models, 2D drawings, and design studies using PDM and PLM systems.
  • Participate in design and drawing reviews.
  • Design, fabricate, assemble, and validate assembly/test fixtures for production of new and existing products.
  • Perform safety risk analysis to assure the safety and efficacy of the device.
  • Perform technical/functional risk analysis to uncover engineering and project risks.
  • Review test data against established pass criteria.
  • Write clear, data-driven technical summaries and test reports.
  • Manage and maintain device drawing package and BOM.
  • Support research initiatives.

 

Manufacturing Responsibilities and Duties:

 

  • Transfer designs to qualified manufacturing partner to ensure high quality and efficient manufacture of products and packaging.
  • Ensure appropriate selection and qualification of vendors and contract service providers.
  • Provide technical oversight and support to sustain production of products manufactured at remote locations including the resolution of 1st and 2nd tier supplier issues.
  • Evaluate engineering change requests to determine impacts on design and process.
  • Identify opportunities for cost reduction. Implement process and design improvements to achieve cost reduction goals.

 

Other Responsibilities:

 

  • Support use of robotic surgical system in preclinical and clinical environments.
  • Train clinical support specialists in understanding design and operation of complex medical system.

 

Education/Experience:

 

  • Bachelor of Science degree in mechanical, electrical, or biomedical engineering.
  • 2 years of design engineering experience.
  • Prior medical or ISO 9001 device experience is required.
  • Familiarity with manufacturing processes is highly desirable.
  • SolidWorks software experience is required.
  • Experience with hand fabrication/electromechanical assembly is desirable.
  • Robotics experience is desirable.

 

Titan Medical is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of this position.

 

Recruiting Agencies, Please Note:

Titan Medical will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Titan Medical via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Titan Medical. No fee will be paid in the event the candidate is hired by Titan Medical as a result of the referral or through other means.

 

 

 

 

 

 

Sr. Manufacturing Engineer – Chapel Hill

January 19, 2021

Position Summary:

This position is accountable for manufacturing related aspects of Titan Medical’s surgical robotic System.  The Senior Manufacturing Engineer will lead and review fixture and process  development, identify issues, and develop programs to ensure alignment with corporate goals and timelines related to manufacturing.  Demonstrable expertise designing complex electro-mechanical fixtures and a proven track-record of working in a manufacturing environment bringing medical devices to market are critical to this role.

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Responsibilities and Duties:

  • Develop, support and troubleshoot manufacturing processes for complex surgical robotic system.
  • Work with R&D team members on multiple projects to ensure design for manufacturability.
  • Coordinate the design, procurement, build and debug of tooling, machinery, and test equipment.
  • Support Process FMEAs and production transfer documentation.
  • Keep stakeholders informed of project status and/or issues related to the manufacturing process.
  • Provide technical leadership through root cause analysis, and resolve project related problems including materials, assembly, functional, or any other manufacturing related issue.
  • Support all Company initiatives as identified by management.
  • Conduct validations independently and assist technicians and junior engineers in executing validation protocols (IQ/OQ/PQ)
  • Work cross functionally with Quality and Operations as part of the “material review board” to ensure product quality.
  • Provide technical guidance and mentorship to engineers and technicians.
  • Other duties as assigned.

 

Education/Experience:

  • Bachelor of Science degree in mechanical or manufacturing engineering minimum
  • 8 years of engineering experience including design and manufacturing roles preferred
  • Working knowledge of manufacturing processes related to medical device manufacturing is highly desired
  • Experience with Solidworks or other CAD software desirable
  • Lean Six Sigma experience desired
  • Ability to prioritize and work independently as a self-starter with strong proactive work ethics
  • Ability to manage multiple projects and responsibilities
  • Experience using statistical methods and software (i.e. Minitab)
  • Experience with product transfers from development to production preferred
  • Good oral and written communication skills
  • Ability to prioritize and work independently
  • Familiar with FDA documentation requirements, QSR and Good Manufacturing Practices
  • Knowledge of process improvement methodology
  • Experience writing and performing IQ/OQ/PQ

 

Titan Medical is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of this position.

 

Recruiting Agencies, Please Note:

Titan Medical will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Titan Medical via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Titan Medical. No fee will be paid in the event the candidate is hired by Titan Medical as a result of the referral or through other means.

 

Quality Assurance Engineer – Chapel Hill

January 19, 2021

Position Summary:

Reporting to the Quality Manager, this individual performs duties in the maintenance and daily operation of the Quality Management System of Titan Medical.  Consistent with the company’s Standard Operating Procedures, the Quality Assurance Engineer will assist internal and contract design organization(s) and contract manufacturing organization(s) to ensure compliance of their processes and deliverables with regulatory guidelines and with Titan Medical’s processes and procedures.

 

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The following key attributes are required:

  • Flexibility to perform a wide range of activities
  • Outstanding people skills; friendly, confident, competent, great communicator, honest, and sincere
  • Must be a dynamic personality and willing to work within a collaborative team environment

 

Quality Management Responsibilities and Duties:

  • Maintenance of Titan Medical’s Quality Management System (QMS)
  • Operation of the daily operation of the QMS
  • Operation of the Arena QMS software and other PLM Software as required
  • Prepare for and assist during regulatory agency audits
  • Conduct statistical analysis including sample size justifications
  • Create, guide, and assist with Test Method Validations (TMV)
  • Interact with subcontractors for contract design activities
    • Interact with supplier’s QA/RA and ensure compliance to all applicable regulations and Titan’s QMS requirements
    • As needed and as appropriate, transfer quality documents to and from Titan
    • Understand and integrate customer and supplier requirements related to the design(s)
    • Perform necessary actions to maintain timely calibrations of measuring equipment and maintenance of manufacturing equipment
    • Manufacturing in-process and final inspections
  • Work with Titan hardware and software design teams
    • Assist with compliance to all applicable regulations and Titan’s QMS requirements
    • Attend ream meetings including design reviews and phase reviews
    • Assist with software testing and other validation testing as appropriate
  • Interact with subcontractors for Contract Manufacturing activities
    • Ensure subcontractor’s Quality System procedures function in alignment with Titan’s Quality System requirements.
    • Assist with post market surveillance and reporting to regulatory agencies
  • Coordinate information from subcontractors for preparation for regulatory applications/audits

 

Other Responsibilities:

  • Identify and resolve quality issues
  • Additional duties as required

 

Education/Experience:

  • Bachelor of Science degree in engineering or other scientific discipline, MS preferred
  • 5-10 years of QA and RA experience including software and hardware design quality.
  • Desired experience includes FDA and EU regulations and associated standards: design controls, document controls, design verification and validation, supplier selection and management, hazard analysis techniques, human factors, regulatory approval methods, and overall medical device industry knowledge
  • Prior experience as quality lead on design teams required.

 

Qualifications:

  • Self-motivated, proactive, and independent, with strong organizational skills to handle shifting priorities, multiple projects/tasks with minimal supervision.
  • Understanding of FDA regulations
  • Understanding of the QMS requirements of ISO 13485, ISO 14971, 21 CFR 820
  • Experience with electro-mechanical device and software validations.
  • Demonstrated ability to contribute to both in-house teams and contract partners.
  • Excellent writing skills; ability to write procedures, work instructions, etc.
  • Computer skills, including WORD, Excel, etc.
  • Good organizational, planning and time management skills.

 

Work Environment and Physical Demands:

  • Overtime may be necessary as workloads dictate. This may include weekdays, weekends and/or holidays to meet project deadlines.
  • Able to move and lift equipment and supplies up to 70 pounds without mechanical aid.
  • Standing or sitting for long periods may be required.
  • Ability to see computer terminal and electronic displays on devices (with or without prescription glasses).

 

Titan Medical is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of this position.

 

Recruiting Agencies, Please Note:

Titan Medical will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Titan Medical via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Titan Medical. No fee will be paid in the event the candidate is hired by Titan Medical as a result of the referral or through other means.

 

 

 

 

 

 

 

 

 

Software Engineer – Chapel Hill

January 14, 2021

Position Summary:  This individual shall develop software for Titan Medical’s surgical robotic system.  This includes developing detailed designs and implementing code that meets the specifications in the software design and software architecture. Additionally, this individual will create unit tests, integration tests, and participate in design reviews and code reviews. Software will be developed using software development life cycle (SDLC) standards from IEC 62304.

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Product Development Responsibilities:

  • Design, and implement embedded medical device software using C/C++ and Object Oriented Design and programming methodologies (OOP/OOD)
  • Design and develop software/firmware solutions for embedded control systems of a surgical robot
  • Follow standards and corporate procedures to ensure proper implementation of all software requirements and verification tests
  • Participate in design and code reviews. Thoroughly assess the ability of proposed designs to meet specified requirements, including manufacturability and testability
  • Conform to the IEC 62304 standards for the design and development of medical device software

 

Administrative Responsibilities and Duties:

  • Provide input to Director Software Engineer and management on progress of projects
  • Provide input for schedules

 

Education/Experience:

  • S. in Computer Engineering, Computer Science, or Electrical Engineering required.
  • 5+ years of demonstrated experience developing large scale software systems is required, medical devices preferred

Qualifications:

  • Embedded software development
  • C/C++, including C++ 14, with in-depth knowledge of OOD/OOP
  • Experience with real-time operating systems (RTOS) such as QNX or VxWorks preferred
  • Prefer experience with medical device software development (IEC 62304) or experience in regulated industries
  • Self-motivated, proactive, and independent
  • Strong communication skills with the ability to interact effectively with people at all levels of the organization

 

Work Environment and Physical Demands:

  • Duties will be split between office environment and laboratory
  • Overtime may be necessary as workloads dictate. This may include weekdays, weekends and/or holidays to meet project deadlines
  • Standing or sitting for long periods may be required
  • Ability to see computer terminal and electronic displays on devices (with or without prescription glasses)

 

Titan Medical is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of this position.

 

Recruiting Agencies, Please Note:

Titan Medical will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Titan Medical via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Titan Medical. No fee will be paid in the event the candidate is hired by Titan Medical as a result of the referral or through other means.

 

Electrical Engineer – Chapel Hill

January 14, 2021

Position Summary:

The electrical engineer is responsible for the development of electrical components of Titan Medical’s surgical robotic system. The Titan robotic surgical platform is a complex collection of interoperating subsystems whose electrical components span the disciplines of power supply design, embedded systems, networking, motor drives, sensor design, signal processing, controls, imaging, safety/electrical compliance, and more. Demonstrable expertise designing complex electrical systems and a proven track-record of working with mechanical and software teams in bringing medical devices to market are essential.

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Responsibilities and Duties:

  • Design, iteration, and release of PCBAs and wiring harnesses, EMC/EMI shielding, and ground path management
  • Create and release documentation packages for PCBAs, including assembly and test specifications
  • Perform engineering qualification of new designs (board bring-up, cable harness verification, etc.)
  • Perform safety risk analysis to assure the safety and efficacy of the products and subsystems
  • Perform technical/functional risk analysis to uncover engineering and project risks
  • Develop verification and validation plans and protocols to test designs against requirements and customer needs
  • Write clear, data-driven technical summaries and test reports
  • Provide documentary support for regulatory filings
  • Support research and development initiatives

 

Education/Experience:

  • Bachelor of Science degree in electrical engineering minimum
  • 2-3 years of engineering experience including design and manufacturing
  • Prior medical device experience or similar regulatory environment is required
  • Strong PCBA design skills with ECAD package such as Altium Designer, OrCAD, or similar
  • Strong cable harness design and documentation skills
  • Strong understanding of electrical compliance, including EMC, safety, and medical safety standards
  • Experience with the following:
    • Motor drives/encoders/mechanical sensors and robotics
    • Optomechanical/optoelectronic systems: cameras, fiber optics, etc.
    • High speed design with (eg) LVDS, Mipi or other SERDES standards
    • Power supply design/debugging
    • EMC considerations for HV/HF systems

 

Titan Medical is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of this position.

 

Recruiting Agencies, Please Note:

Titan Medical will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Titan Medical via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Titan Medical. No fee will be paid in the event the candidate is hired by Titan Medical as a result of the referral or through other means.

 

 

Director or Sr. Manager Engineering – Chapel Hill

January 14, 2021

Position Summary:

This position is responsible for managing the Titan Medical’s Robotic Assisted Surgical Device system that are safe and effective, while meeting expectations on performance, budget, timeline, and commercial readiness. This position works closely with Titan Medical’s Senior Vice President of R&D to translate corporate objectives into project plans for managing electromechanical engineering resources (internal and external). Full command of engineering principles, risk assessment, and standards-based methodology in the context of medical device development are musts. A key element of success for this role is effective planning and execution.

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Design Engineering Responsibilities and Duties:

  • Manage development of the electromechanical design
  • Contribute to the Design History File, including requirements, verification & validation, risk analysis, documentation, design reviews, and change management.
  • Develop and manage a highly motivated, results oriented engineering team that is scaled to meet Titan Medical’s corporate goals.
  • Ensure a robust, quality centric product development process is maintained and followed.
  • Identify and manage resources required to ensure rapid, efficient, and effective execution of R&D initiatives.
  • Contribute to strategic roadmap ensuring new technologies and methods are recognized and explored.
  • Work with executive management to ensure alignment on prioritization of goals and projects.

Manufacturing Responsibilities and Duties:

  • Transfer designs to qualified manufacturing partner to ensure high quality and efficient manufacture of products and packaging.
  • Ensure appropriate selection and qualification of vendors and contract service providers.
  • Provide technical oversight and support to sustain production of products manufactured at remote locations including the resolution of 1st and 2nd tier supplier issues.
  • Evaluate engineering change requests to determine impacts on design and process.
  • Identify opportunities for cost reduction. Implement process and design improvements to achieve cost reduction goals.

 

Other Responsibilities:

  • Develop and maintain department budget.
  • Identify and manage vendors for product development support and manufacturing.
  • Support use of robotic surgical system in preclinical and clinical environments.
  • Identify and resolve quality issues.
  • Support regulatory filings.
  • Perform team member reviews and evaluations.

Education/Experience:

  • Bachelor of Science degree in mechanical, electrical, or biomedical engineering, MS preferred.
  • Minimum of 10 years of engineering experience including design and manufacturing.
  • Substantial experience in a similar role is required.
  • Prior medical device experience is required.
  • ISO13485 experience is required.
  • Familiarity with manufacturing processes is highly desirable.
  • SolidWorks software experience is required.
  • Robotics experience is desirable.

 

Titan Medical is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of this position.

 

Recruiting Agencies, Please Note:

Titan Medical will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Titan Medical via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Titan Medical. No fee will be paid in the event the candidate is hired by Titan Medical as a result of the referral or through other means.