Senior Product Engineer - Medical Device

About the Opportunity

Our client is a growing medical device manufacturer that develops innovative products used in minimally invasive and image-guided procedures across multiple therapeutic areas. They are seeking a Product Engineer III to join their Research & Development team and play a key role in supporting both new product development initiatives and existing product enhancements.

This position offers the opportunity to work closely with cross-functional engineering teams while contributing to product performance evaluations, design verification activities, risk management efforts, and product development processes within a regulated medical device environment.

The Product Engineer III will lead and participate in engineering activities that support the development and improvement of medical devices. This individual will leverage knowledge of design controls, medical device testing methodologies, engineering statistics, and industry standards to ensure products are effectively verified and validated throughout the development lifecycle.

• Conduct engineering studies to evaluate product performance and generate data that supports product development activities.
• Partner with systems, mechanical, quality, and cross-functional teams to ensure product requirements are measurable and verifiable.
• Develop and validate test methods utilizing industry standards, engineering principles, and best practices.
• Support product investigations through root cause analysis, failure analysis, and statistical evaluation techniques.
• Develop Design Verification Plans, protocols, reports, and engineering rationales.
• Conduct preclinical testing and product performance assessments.
• Support technical discussions related to product design tradeoffs, risk mitigation strategies, and regulatory responses.
• Develop clinically relevant simulated-use and bench‑top testing models.
• Ensure compliance with FDA regulations, design controls, quality system requirements, and applicable international standards.
• Participate in risk management activities and support the review and mitigation of product risks.
• Execute testing activities, document observations, and communicate findings to cross‑functional stakeholders.
• Provide technical guidance to engineering team members and support laboratory activities as needed.

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Biological Sciences, Physical Sciences, or a related discipline.
• Minimum of four (4) years of experience within the medical device industry.
• Strong understanding of FDA Design Controls and applicable medical device regulations.
• Experience with product verification and validation activities within a regulated environment.
• Knowledge of industry standards such as ASTM, ASME, ISO, and related testing methodologies.

• Test Method Validation (TMV)
• Measurement System Analysis (MSA)
• Statistical analysis and Design of Experiments (DOE)
• Experience developing fixtures and test equipment for product evaluation.
• Strong technical writing, communication, and project management skills.
• Foundational understanding of manufacturing processes and product development activities.

Ideal candidates will have experience supporting product development activities for disposable or minimally invasive medical devices and possess a strong understanding of product performance testing, risk management, and design verification processes within FDA‑regulated environments.