Lead R&D Engineer
$110,000–$155,000 year
Hybrid · Libertyville, Illinois, United States
Job Summary
Lead R&D Engineer on Hollister Ostomy New Product Development, driving and participating in new product development projects to deliver meaningful value to customers and the business. Responsibilities include concept development, design refinement, 3D modeling, design verification and validation, statistical analysis, and technical leadership. Operates with minimal supervision on technical tasks and uses structured problem-solving to inform decisions. Key skills include CAD (SolidWorks), design controls (DHF, risk management, FMEA, traceability matrices, V&V), stage-gate processes, usability engineering, cross-functional collaboration (marketing, design assurance, engineering, operations, regulatory, clinical), prototyping and hands-on testing, data analysis, and preparation of technical documentation to meet regulatory requirements. The role requires collaboration with clinicians and end-users, development of user needs, and optimization of product performance, as well as strong communication and leadership within multidisciplinary teams. The position is in a hybrid work environment with in-office presence required (minimum 4 days/week) in Libertyville, IL; sponsorship to work in the US is not available at this time. Our total rewards package includes competitive pay, comprehensive benefits, and retirement savings plans.
Required Qualifications
- Bachelor’s degree in technical discipline with 8 years minimum of related medical device experience OR Master’s Degree in technical discipline with 6 years minimum of related medical device experience
- Proficiency with Design Controls including documentation of design history files (DHF), risk management files, failure mode effects analysis (FMEA), traceability matrices, and verification and validation (V&V) processes
- Experience in designing and developing medical devices across various stages (concept, prototyping, testing, production)
- Experience as a technical leader within multidisciplinary teams (marketing, design assurance, engineering, operations, regulatory, clinical, etc.)
- Hands-on experience with prototyping and CAD modeling
- Ability to lift 15-25 kg (physical requirements)
- Strong verbal and written communication skills in English
- Ability to travel as needed to Hollister manufacturing facilities and vendor locations
- Bachelor’s or Master’s degree in a technical discipline with relevant medical device experience
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