Development Sr Engineer

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 yearsmedical device product development strongly preferred.
• Hands-on experience withDesign Controls, Risk Management, and regulated medical devices.
• Knowledge of21 CFR Part 820/QSR, ISO 13485, and ISO 14971.
• Experience withNPD, feasibility, design changes, technology integration, or manufacturing/product transfer.
• Strongtechnical writing, documentation, communication, and cross-functional project coordination.
• Engineering statistics:sample size, DOE, hypothesis testing.
• Microsoft Office proficiency.
• Able to work3 days onsite in Warsaw, IN and travel up to 25%.