Principal R&D Engineer
About The Position
The Principal Research & Development Engineer is a technical leader responsible for the design, development, verification, validation, commercialization, and lifecycle management of medical device products. The role provides strategic and technical leadership across product development, ensuring compliance with design control requirements, regulatory standards, quality systems, and engineering best practices. The engineer leads complex product development and sustaining engineering initiatives and serves as a subject matter expert in product design, risk management, verification and validation, and change management. The role works cross-functionally with Quality Assurance, Regulatory Affairs, Manufacturing, Clinical Affairs, Human Factors, Marketing, suppliers, and external partners to deliver safe, effective healthcare solutions. The Principal R&D Engineer also drives continuous improvement, supports technical problem-solving and root cause investigations, mentors engineering teams, influences technical strategy, and guides critical business decisions. Products must meet customer needs, intended-use requirements, and regulatory expectations throughout their lifecycle. The role may involve working with teams in the US, Asia, and other locations, transferring products from R&D to manufacturing, and travel as needed.
Requirements
- Bachelor’s degree or higher in Biomedical Engineering, Mechanical Engineering, or a related field is preferred.
- Four or more years of relevant medical device experience is preferred.
- Proven track record of successful technical project management in a product development environment is preferred.
- Knowledge of medical device design controls and stage-gate product development processes is preferred.
- Knowledge of mechanical systems, plastic injection molding, and component design is preferred.
- Ability to work with diverse teams across multiple locations.
Nice To Haves
- Design for Six Sigma (DFSS) certification is preferred.
- Experience with CAD, preferably SolidWorks, is a plus.
- Manufacturing experience is a plus.
- Patent experience is a plus.
- Experience with Microsoft Project is preferred.
Responsibilities
- Lead medical device new product development, product enhancements, and sustaining engineering programs.
- Develop and execute design strategies that incorporate applicable FDA, ISO, IEC, and EN medical device standards.
- Provide technical leadership for medical device 510(k) submissions for new products and work on complex, large-scope projects.
- Contribute to the development of policies and procedures.
- Write and review technical specifications.
- Conduct technical and design reviews.
- Write protocols and reports for technical work, including design verification and validation.
- Conduct or coordinate finished-device and part-level testing.
- Complete product development tasks and documentation required for design controls and the Design History File, and perform risk management according to established SOPs.
- Provide presentations, reports, and schedules to manage projects and communicate status, risks, and issues.
- Develop solutions to technical issues and implement them through the established Change Development Process.
- Collaborate with diverse teams across US, Asia, and other locations, including Quality, Regulatory, Manufacturing, other technical groups, and third-party design engineering resources.
- Transfer products from R&D to manufacturing.
- Travel as needed to support and drive projects.
Benefits
- Medical, dental, and vision coverage
- Paid time off plan
- Health savings account (HSA)
- 401(k) savings plan
- Access to wages before payday with myFlexPay
- Flexible spending accounts (FSAs)
- Short- and long-term disability coverage
- Work-Life resources
- Paid parental leave
- Healthy lifestyle programs
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What This Job Offers
Job Type
Full-time
Career Level
Principal
