Cresilon
Senior Medical Device Research and Development Engineer
$100K–$160K
Brooklyn, New York · Senior · Full-time · Posted Sep 1, 2026
- Experience
- 5+ years of product development; 4 years of hands-on new product R&D in a cGMP-regulated industry.
- Education
- BS in a listed or related scientific discipline.
- Visa sponsorship
- Legal authorization to work in the United States is required.
About the job
Leads research, design, development, testing, and documentation for medical devices and combination products, including polymeric materials, implants, and instruments, under applicable quality and regulatory controls.
What you'll do
- Lead product development experiments, prototype design, testing, and performance characterization, and develop test methods and verification/validation plans.
- Lead cross-functional product development and design changes; define requirements and address design, safety, reliability, and cost considerations.
- Author design history files, technical protocols and reports, and other documentation for regulated product development and submissions.
What they ask for
- BS in Chemical Engineering, Polymer Engineering, Material Science, Biomedical Engineering, Mechanical Engineering, or a related scientific discipline.
- 5+ years of product development experience and 4 years of hands-on new product R&D experience in a cGMP-regulated industry.
- Hands-on medical device R&D experience, including safety/efficacy characterization, user needs and technical inputs, and verification/validation planning.
- Working knowledge of FDA requirements, ISO 9001, ISO 13485:2003, ISO 14971:2007, GDP, and cGMP; legal authorization to work in the United States.
Nice to have
- Advanced degree (MS or Ph.D.); Class II or Class III medical device development experience.
- Experience with IDE and PMA submissions; Six-Sigma green belt or black belt certification.
Pay
$100,000 - $160,000 (base salary)
Tools
Solidworks, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, FDA Quality System Regulations, ISO 13485, ISO 14971, cGMP
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