Product Development Engineer I
On-siteMinnetonka, Minnesota, United States
Job Summary
Design and develop new and existing medical devices by creating specifications, prototypes, and design documentation in compliance with regulatory and quality requirements. Conduct risk assessments, design reviews, and verification testing to ensure product safety and efficacy while collaborating cross-functionally with NPI, manufacturing, quality, and regulatory teams. Build and test prototype devices, select materials, and develop processes and characterization studies to support manufacturability and cost-effectiveness. Manage project tasks, coordinate testing activities with internal and external partners, and resolve technical issues during product launches. Research new technologies and support feasibility assessments under senior engineer guidance.
Required Qualifications
- Bachelor's/University degree in Engineering (Mechanical, Biomedical, etc.), or related science/technical field
- 0-3 years of engineering in medical device or related industry experience (or Internship or academic experience)
- Familiarity with GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements
- Working knowledge or coursework in 3D solid modeling and technical drawings
- Basic understanding of creating prototypes using various materials and techniques to test and validate product designs
- Awareness of Design for Manufacturability (DFM) principles to design products that are manufacturable and cost effective
- Ability to communicate technical ideas clearly, ask thoughtful questions, and document work accurately
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.