What are the responsibilities and job description for the Biomedical Engineer - Mechanical position at Career Opportunities at Merz North America?
About the Company:
Family owned since 1908 Merz Aesthetics is the world’s largest dedicated medical aesthetics business. Choose Merz Aesthetics because it is unique - unique in our relationships with customers, in our products and in the way we treat each other.
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.
- Assist the engineering team on implementing test plans, design analysis, making design adjustments, running performance calculations, and maintaining quality standards.
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.
Education:
- Bachelor in Mechanical Engineering or equivalent experience or relevant engineering discipline. Required
- Master’s in Mechanical engineering.
Experience:
- 2-5 years ME experience. Required
- 2-5 years of related design / development or service experience in the medical device and/or component. Required
Knowledge Skills and Abilities:
- FDA Design Controls and EU Medical Device Directive (CE Marking requirements).
- Knowledge and experience with application of Six Sigma statistical analysis and controls.
- Understanding of Ultrasound Understanding of Ultrasound.
- Knowledge and experience with field service.
- Excellent project management skills. Required
- Previous experience in field service or service operations.
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!