Senior Medical Device Research and Development Engineer
$100,000–$160,000 year
On-site · Brooklyn, New York, United States
Job Summary
Senior Medical Device R&D Engineer leads design and development of medical devices and combination products, drafts technical documentation under Design Control, provides project-specific technical analysis and supplier reviews, and drives prototype design, data generation, and risk/validation activities. The role involves leading cross-functional teams to define design inputs, evaluate reliability and safety, maintain design history files, develop implants/instrument designs using SolidWorks, and ensure compliance with FDA QSR/ISO 13485 design/control requirements, with hands-on experimentation, interdisciplinary collaboration, and communication of results to internal teams and external stakeholders.
Required Qualifications
- BS in Chemical Engineering, Polymer Engineering, Material Science, Biomedical Engineering, Mechanical Engineering, or related scientific discipline
- A minimum of 5+ years of product development experience
- A minimum of 4 years of hands-on experience in new product research and development in a cGMP-regulated industry
- Hands-on experience in medical devices safety/efficacy characterization in an R&D environment
- Experience translating user needs to technical inputs and developing V&V plans
- Experience leading complex product development initiatives from concept through launch
- Strong knowledge of anatomy and surgical procedures
- Ability to design experiments and analyze data with quality and statistics methodologies
- Ability to work independently and cross-functionally in a fast-paced environment
- Leadership and communication skills
- FDA requirements knowledge (21 CFR 820) and ISO 9001/13485/14971 familiarity
- GDP and cGMP knowledge
- Statistical tools and validation techniques
- Proficiency with Microsoft Office tools
- Legal authorization to work in the United States
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