What are the responsibilities and job description for the Biomedical Engineer - Mechanical position at Merz North America, Inc?
Quality
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 a mechanical engineering foundation, having at least 2 years of experience developing and sustaining regulated electro-mechanical device design and process, to support the Ultherapy medical device product portfolio. Key Responsibility :
- Design and Development : Maintain and improve electro-mechanical medical device design, manufacturing, and service process. 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 electrical 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 mechanical 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 and R&D. Assist with label artwork using Adobe Illustrator. Knowledge Skills and Abilities :
- FDA Design Controls and EU Medical Device Directive (CE Marking requirements).
- Knowledge and experience with application of Six Sigma statistical analysis and controls.
- SolidWorks expertise.
- Understanding of Ultrasound.
- Excellent project management skills. Required
- Previous experience in manufacturing and / or service operations. Education :
- Bachelor in Mechanical Engineering or equivalent experience or relevant engineering discipline. Required
- Master’s in Mechanical engineering. Experience :
- At least 2 years of mechanical engineering experience designing, developing, and / or sustaining electro-mechanical products in a regulated industry (e.g., medical device, automotive, aerospace). 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! Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
