Sr Biomedical Engineer -Systems

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.

An experienced engineer, with a systems and electrical engineering foundation, having at least 8 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: Lead and manage critical activities related to maintaining and improving Electro-mechanical medical device design, manufacturing, and service processes.

Participate in reliability studies.

Lead 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.

Mentor junior engineers.

Knowledge Skills and Abilities:


* FDA Design Controls and EU Medical Device Directive (CE Marking requirements).


* High level of experience with system level requirements definition.


* PCB 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 simulations project management skills.


* Knowledge and understanding of RF circuitry (Preferred).


* Previous experience in manufacturing and/or service operations (IQ, OQ, PQ).


* Practical knowledge of Six Sigma methodologies.

Green or Black Belt certification (Preferred)

Education:


* Bachelor of Science in Biomedical Engineering, Electrical Engineering, or related engineering discipline.

Required


* Master of Science in Engineering.

Experience:


* At least 8 years of systems and/or electrical engineering experience designing, developing, and/or sustaining electro-mechanical products in a regulated industry (e.g., medical device, automotive).

Be...