Biomedical Product Engineer – Invacare Corporation
Invacare Corporation is a leading manufacturer and distributor of non-acute healthcare products, including power wheelchairs, home respiratory equipment, and mobility aids used by millions of people worldwide. Our Elyria, OH headquarters is seeking a Biomedical Product Engineer to support ongoing product development and quality improvements for our home medical equipment portfolio.
Responsibilities
- Support design and testing of power mobility devices, home respiratory equipment, and manual wheelchairs
- Execute product verification and validation testing per FDA 21 CFR Part 820 and relevant IEC standards
- Assist with failure analysis, CAPA investigations, and field action assessments
- Develop and review engineering drawings, BOMs, and technical documentation
- Collaborate with manufacturing and supply chain teams during product sustaining activities
- Support regulatory submissions for FDA 510(k), CE Mark, and international approvals
Requirements
- BS in Biomedical Engineering, Mechanical Engineering, or Electrical Engineering
- 0-2 years product engineering experience in regulated medical device or durable medical equipment sector
- Familiarity with IEC 60601 standards for electrical medical equipment
- Proficiency in SolidWorks or Pro/E CAD software is a plus
- Strong technical writing skills and documentation discipline
Benefits
- Competitive salary and annual merit review
- Medical, dental, and vision insurance options
- 401(k) retirement savings plan with company match
- Paid holidays and PTO accrual
- Collaborative work culture focused on serving patients with disabilities