Principal R&D Engineer
On-site · Saint Paul, Minnesota, United States
Job Summary
Principal R&D Engineer responsible for designing and developing new division medical devices or components, leading prototypes from concept through testing, ensuring compliance with FDA/ISO design controls, and coordinating with vendors, consultants, and the medical community. Roles include empirical/experimental analysis, material-based device concepts, prototype construction, project planning and risk mitigation, supporting animal/bench testing and clinical evaluations, design reviews, and maintaining knowledge of evolving clinical needs. Requires expertise in biocompatible materials, mechanical design of implants and delivery systems, plastics and metals processing (injection molding, extrusion, thermoforming, packaging, sterilization), and international travel.
Required Qualifications
- Bachelor's degree in Mechanical Engineering or related field
- Master's degree in Mechanical Engineering or related field
- Mechanical Engineering experience with 10+ years in R&D
- Experience designing and testing medical devices
- Experience with manufacturing processes and design for manufacturability
- Project leadership and management skills
- Plastics injection molding and/or extrusion experience
- Metals experience a plus (stainless steel and nitinol wires)
- CAD experience with ProE and/or SolidWorks
- Knowledge of Six Sigma, Design for Manufacturability, Analytical Design
- Ability to travel internationally
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