Biomedical Engineer jobs in Racine, WI

About the Company: 

Merz is a family-owned medical device and pharmaceutical company headquartered in Germany. Our Global Technical Operations based in WI manufactures, packages and ships several innovative products so that people all over the world can live better, feel better, and look better.

Key Responsibility:  

Installed Base Support:

• Provide continuing product support for manufacturing, regulatory and quality on design requirements, customer needs, testing, CAPA, reliability predictions, and product documentation.

Product Design Support – Serviceability: 

• Assist the engineering team on implementing test plans, design analysis, making design adjustments, running performance calculations, and maintaining quality standards.

Supply Continuity:

• Support of the Engineering Change Order (ECO) process per Design Controls – Design Change regulations and internal policies.
• Provide continuing product support for manufacturing, regulatory and quality on design requirements, customer needs, testing, CAPA, reliability predictions, and product documentation.

Service Methods:

• Develop and implement continuous improvement against current service methodologies.

Compliance:

• Ensure compliance to the requirements of ISO 13485 standards, FDA regulations and Good Manufacturing Processes regarding service and repair of new product launches and product upgrades.

Knowledge and Skills:

• FDA Design Controls and EU Medical Device Directive (CE Marking requirements). Preferred
• High level of experience with system level requirements definition. Preferred
• PCB Design and Analysis experience and understanding, grounding / EMI considerations. Preferred
• Understanding of Ultrasound. Preferred
• Knowledge and experience with field service. Preferred
• Excellent project management skills. Preferred
• Knowledge and understanding of RF circuitry. Preferred
• Previous experience in field service or service operations. Preferred

Education:

• Bachelor’s in electrical engineering or relevant engineering discipline. Required
• Master’s in electrical engineering. Preferred

Experience:

• 3-5 years employee experience. Preferred
• 3-5 years of related design / development or service experience in the medical device and/or component. Preferred

Benefits:

• Comprehensive Medical, Dental, and Vision plans
• 20 days of Paid Time Off
• 15 paid holidays
• Paid Sick Leave
• Paid Parental Leave
• 401(k)
• Employee bonuses
• And more!

Your benefits and PTO start the date you're hired with no waiting period!
Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees!