Note: The job is a remote job and is open to candidates in USA. Accordance Search Group is representing a market-leading manufacturer of infection prevention and patient safety products seeking a Product Development Engineer. This role involves leading cross-functional projects, translating user needs into design requirements, and ensuring compliance with FDA and ISO standards.
Responsibilities
- Lead cross-functional projects, translate user needs into design requirements, and validate designs
- Work under FDA 21 CFR 820.30 Design Controls, ISO 13485, and ISO 14971 Risk Management
- Collaborate with manufacturing to seamlessly transfer designs to production
Skills
- 3+ years of medical device engineering experience
- Proficiency in CAD software (SolidWorks, AutoCAD, or Pro/E)
- Lead cross-functional projects, translate user needs into design requirements, and validate designs
- Work under FDA 21 CFR 820.30 Design Controls, ISO 13485, and ISO 14971 Risk Management
- Collaborate with manufacturing to seamlessly transfer designs to production
- Up to 10% travel
- BS in Engineering (Mechanical, Biomedical, Material-Science, or Manufacturing preferred)
Benefits
- Competitive benefits & 401k match
- Remote option available (must reside within 3 hours of Neenah, WI OR Lincolnshire, IL)
Company Overview