R&D Mechanical Engineer
About the position Join a research and development team supporting the design and development of mechanical components, fixtures, and tooling for medical devices and related processes. This role contributes to product development activities from concept through release, working under guidance to deliver compliant designs, documentation, and verification results. You will collaborate across functions to support project execution in a regulated environment. Work Flexibility: Hybrid: candidates must reside within commuting distance of Tempe, AZ and be able to work onsite several days per week.
Responsibilities
- Design and develop mechanical components, fixtures, and tooling for medical devices, progressing concepts through verification and release
- Translate user needs, design inputs, and process requirements into engineering specifications and component-level designs
- Develop prototypes and evaluate multiple design solutions using data to support design decisions
- Conduct design reviews and support verification activities, addressing risks, interfaces, and usability considerations
- Perform root cause analysis on design or process issues and implement corrective design changes
- Create and maintain engineering documentation, including drawings, reports, and verification records with traceability
- Apply regulatory standards, design controls, and risk management practices during development activities
- Collaborate with cross-functional teams (Quality, Manufacturing, Regulatory, Clinical, Marketing) to meet project milestones
Requirements
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related engineering discipline
- Experience in engineering design or product development within a regulated environment
- Experience creating engineering drawings and models using CAD tools
- Experience applying basic engineering principles, materials, and manufacturing processes
- Experience in medical device product development
- Experience with design controls, risk management, and quality systems
- Experience developing prototypes and supporting verification testing
- Experience applying GD&T standards (e.g., ASME Y14.5)
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