Position Overview:
Leads and participates in the development of medical devices by leveraging knowledge of industry standards/test methods, clinical use, the product development process and design controls to ensure design input requirements are verifiable and by management of design verification and validation activities.
What you will do:
- Develop data through engineering studies that informs new product development team about performance of the product and competitors.
- Partner with systems and mechanical design engineers in defining product requirements such that they are verifiable.
- Leverage regulatory standards from ASTM, ASME, ISO, etc., Engineering DOEs, and general industry best practices for developing Test Methods.
- Support the mechanical design engineers to solve problems and utilize engineering best practices and techniques for root cause (failure analysis) and statistical analysis (engineering rationales).
- Develop Design Verification Plans, Protocols & Reports. Conduct preclinical design verification and design iteration assessments of products.
- Support technical discussions for projects including system design trade-offs, product risk mitigation, technical problem and responses for regulatory submission.
- Support Clinical engineering and Up-Stream marketing to develop clinically relevant simulative use bench top models.
- Ensure compliance to the product development process and Quality System and Design Control requirements.
- Support mechanical design and cross-functional team members through the review of risk management file to mitigate the product risk.
- Develop understanding of the scientific, technical, medical, and clinical aspects of company devices and features and the disease states they aim to treat.
- Execute testing per protocols and record and communicate the test results, observations, failure modes, and deviations clearly to cross-functional team members.
Skills for Success:
- BS Degree or higher in Biomedical, Mechanical, Electrical, Biological, or Physical Science required.
- 4 or more years of medical device industry experience.
- Strong knowledge and ability to use industry standards and regulations for medical devices.
- Foundational understanding of standard manufacturing processes.
- Strong understanding of design controls per FDA and MDD/MDR requirements.
- Strong experience with medical device testing, test method validations (TMV), gauge R&R, and measurement system analysis (MSA)
- Ability to design, development, and production of fixtures for inspection and testing.
- Demonstration of time management to complete tasks on schedule and vertical communication promptly to ensure transparency.
- Use of statistical analysis software and strong fundamental understanding of engineering statistics for the medical device industry.
- Travel 5-10%
Supervisory responsibilities- May supervise activities within the test lab and manage calibration and safety of the lab environment.
- May provide guidance to other R&D team members and cross-functional team members.
