Job Description
Job Title: Development Sr Engineer
Location: Warsaw, IN 46580 – Hybrid (3 days onsite)
Duration: 12 Months
Travel: Up to 25%
Must-Have Requirements
- Bachelor’s degree in Engineering; Mechanical, Biomedical, Bioengineering, Materials, Chemical, Polymer or related preferred.
- 3+ years relevant engineering experience; 3–5 years medical device product development strongly preferred.
- Hands-on experience with Design Controls, Risk Management, and regulated medical devices.
- Knowledge of 21 CFR Part 820/QSR, ISO 13485, and ISO 14971.
- Experience with NPD, feasibility, design changes, technology integration, or manufacturing/product transfer.
- Strong technical writing, documentation, communication, and cross-functional project coordination.
- Engineering statistics: sample size, DOE, hypothesis testing.
- Microsoft Office proficiency.
- Able to work 3 days onsite in Warsaw, IN and travel up to 25%.
Skills
Bioengineeringunmatched
Biomedicineunmatched
Career Developmentunmatched
Code of Federal Regulationsunmatched
Cross-Functionalunmatched
Engineeringunmatched
ISO (International Organization for Standardization)unmatched
Manufacturingunmatched
Medical Equipmentunmatched
Medical Productsunmatched
Microsoft Officeunmatched
Polymersunmatched
Product Developmentunmatched
Project/Program Coordinationunmatched
Quality System Requirements (QSR)unmatched
Risk Managementunmatched
Statisticsunmatched
Technical Writingunmatched
Testingunmatched
United States Department of Energy (DOE)unmatched
Willing to Travelunmatched
Writing Skillsunmatched
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