What are the responsibilities and job description for the Biomedical Engineer – Electrical 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.
Summary:
An engineer, with an electrical engineering foundation, having at least 3 years of experience developing and sustaining regulated electro-mechanical device design and process, to support the Ultherapy medical device product portfolio.
Key Responsibilities:
- Design and Development: Maintain and improve electro-mechanical medical device design, manufacturing, and service processes. Participate in reliability studies. Support in troubleshooting activities, investigate the root cause to a successful conclusion, and help to resolve product complaints and CAPAs.
- Prototyping and Testing: Conduct research and testing to solve problems. Test functionality, safety, and effectiveness. Develop prototypes and conduct testing to ensure devices meet customer needs, design requirements, and regulatory standards.
- Collaboration: Work closely with cross-functional teams, including mechanical engineers, process engineers, quality, and regulatory, to ensure device safety, compliance, compatibility, functionality, manufacturability, and serviceability.
- Regulatory Compliance: Ensure that device complies with relevant regulations and standards (e.g., FDA, CE Mark, IEC 60601 series, ISO 13485, GMP)
- Documentation: Develop detailed electrical drawings. Documentation of design processes and test results. Execute the Engineering Change Order (ECO) process per Design Controls – Design Change regulations and internal policies. Support regulatory submissions.
Education:
- Bachelor of Science in Biomedical Engineering, Electrical Engineering, or related engineering discipline. (required)
- Master of Science in Electrical Engineering.
Experience:
- At least 3 years of electrical engineering experience designing, developing, and/or sustaining electro-mechanical products in a regulated industry (e.g., medical device, automotive, aerospace).
Knowledge Skills and Abilities:
- FDA Design Controls and EU Medical Device Directive (CE Marking requirements).
- High level of experience with system level requirements definition.
- CB Design and Analysis experience and understanding, grounding, EMI, and EMC considerations.
- Understanding of Ultrasound.
- Familiarity with common electronics design tools such as T&M equipment, CAD tools, and simulation.
- Excellent project management skills.
- Knowledge and understanding of RF circuitry . (Preferred)
- Previous experience in manufacturing and/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!
