What are the responsibilities and job description for the Biomedical Engineer – Electrical position at Merz Aesthetics?
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
Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees!
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.
- Bachelor of Science in Biomedical Engineering, Electrical Engineering, or related engineering discipline. (required)
- Master of Science in Electrical Engineering.
- 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).
- 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.
- 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!
Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees!
