Freudenberg Group · 3 months ago
Product Development Engineer I
Freudenberg Medical LLC is a company focused on medical technologies, and they are seeking a Product Development Engineer I. The role involves executing project tasks, creating design documentation, and developing prototypes under supervision.
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Responsibilities
Execute project tasks and/or lead low complexity projects under close supervision
Create/maintain Design Controls documentation in accordance with established regulatory requirements and SOPs
Translate User Needs into Design Input Requirements to comply with regulatory requirements and best-practice standards. Perform testing to verify the design input requirements
Generate CAD models & drawings based on theoretical concepts
Build and test prototype devices
Identify suppliers in the context of product development activities
Coordinate testing with internal or external partners, including Design Validation to ensure devices meet user needs
Facilitate project team meetings
Select materials for prototypes and finished medical devices
Lead or assist in creating technical document, such as protocols and reports
Qualification
Required
0-2 years of Medical Device design & development experience
Bachelor of Science in Mechanical, Biomedical Engineering, or related discipline
21CFR Part 820.30 Design Controls, ISO 13485, ISO 14971 ISO 10993 and IEC 62366
3D solid modelling (e.g. SolidWorks or related software)
Good communication & interpersonal skills
Good mechanical, analytical & problem-solving skills
Willingness to learn and develop new skills
Preferred
Master's degree
Hands-on experience with machining and 3D prototyping methods
Knowledge of silicone and plastic molding
Company
Freudenberg Group
Freudenberg is a global technology group that strengthens its customers and society long-term through forward-looking innovations.
Funding
Current Stage
Late StageLeadership Team
Recent News
2026-01-07
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2025-11-05
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