General Summary
As a Senior R&D Engineer, you will be charged with designing game-changing medical devices to address some of the world’s toughest disease states. You will apply creative problem-solving at all stages of the design process, from concept to commercialization, as you provide technical leadership in the design and development of new devices as well as changes to existing devices, processes, and equipment. This role requires strong independent judgment, technical depth, and the ability to conceptualize, develop, specify, test, and implement new designs.
Specific Duties and Responsibilities
- Design, prototype, and develop new medical devices and components.
- Manage projects as a project leader within a multidisciplinary project team.
- Create comprehensive documentation packages that contain CAD drawings, product specifications, risk analysis, test protocols, test reports, studies, work instructions, etc.
- Document research and development process through lab notebooks, engineering protocols, and engineering reports.
- Execute testing and document, interpret, and communicate test results.
- Identify, vet, and utilize vendors in the development of Penumbra products.
- Perform research and integrate new technologies into existing and future products.
- Train engineers, technicians and assemblers in new processes and methods.
- Evaluate prototypes against standards or specifications and troubleshoot problems to assess root cause and corrective action.
- Adhere to Penumbra’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
- Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to Penumbra.
- Ensure other members of the department follow the QMS, regulations, standards, and procedures.
Position Qualifications
Minimum education and experience:
- Bachelor's degree in Engineering (Mechanical, Biomedical, or related discipline preferred).
- 5+ years of experience in R&D Engineering or Product Development within the medical device industry.
- Experience solving hands-on and multi-disciplinary technical design problems.
- A portfolio demonstrating strong engineering acumen and mechanical intuition.
- Refined soft skills that allow you to lead up and lead down with or without a formal reporting structure.
