Biomedical Engineer – Electrical

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)


* Employ...