Biomedical Engineer - Mechanical at Merz North America Inc in Franksville, Wisconsin

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.

Key Responsibility:

Installed Base Support:

• Provide continuing product support for manufacturing, regulatory and quality on design requirements, customer needs, testing, CAPA, reliability predictions, and product.


• Assist the engineering team on implementing test plans, design analysis, making design adjustments, running performance calculations, and maintaining quality standards. 

Product Design Support – Serviceability: 

• Assist the engineering team on implementing test plans, design analysis, making design adjustments, running performance calculations, and maintaining quality standards. 

Supply Continuity: 

• Support of the Engineering Change Order (ECO) process per Design Controls – Design Change regulations and internal policies. 


• Provide continuing product support for manufacturing, regulatory and quality on design requirements, customer needs, testing, CAPA, reliability predictions, and product documentation. 

Service Methods :

• Develop and implement continuous improvement against current service methodologies.

Compliance:

• Ensure compliance to the requirements of ISO 13485 standards, FDA regulations and Good Manufacturing Processes regarding service and repair of new product launches and product upgrades.

Education: 

• Bachelor in Mechanical Engineering or equivalent experience or relevant engineering discipline. Required 


• Master’s in Mechanical engineering.

Experience:

• 2-5 years ME experience. Required  


• 2-5 years of related design / development or service experience in the medical device and/or component. Required

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. 


• Understanding of Ultrasound Understanding of Ultrasound. 


• Knowledge and experience with field service. 


• Excellent project management skills. Required 


• Previous experience in field service 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!

 

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)

Quality

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