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Biomedical Engineer – Electrical

Category Clinical/Medical/Regulatory Affairs Job Id BIOME003980 Job Type Full Time Posted Date 02/14/2025

JOB DESCRIPTION

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!

Notice of Recruitment Fraud
It has come to our attention that an individual or individuals are fraudulently using the Merz company name to misrepresent opportunities to interview and potentially receive employment offers. These individuals are not affiliated with Merz or acting on our authority. Merz and its affiliates are not responsible for fraudulent correspondence or offers, and recommend candidates follow the guidance below.
Legitimate Merz recruiters can be identified through the @merz.com or @merz.de email domains. All Merz applicants are required to apply for Merz jobs through only our careers pages on our corporate websites:www.merz.comwww.merzusa.comwww.merzaesthetics.com; https://careers.merzaesthetics.com/us/en; https://us.merzaesthetics.com/careers/;  
We encourage you to validate any outreach by contacting our Human Resources team at employee.experience@merz.com.


How to Identify Recruitment Fraud
Fraudulent job offers often ask for financial or personal information early in the process. Merz does not ask for any financial commitment or contribution from a candidate at any stage of the recruitment process. If you believe you have been a victim of a fraudulent job offer concerning Merz, you should not respond, and we encourage you to notify law enforcement by filing a complaint.
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