Process Engineer (Architecture)
About Us
Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics.
A Brief Overview
Provide engineering technical support to the process / product development and sustaining processes for Electrical Mechanical Devices within the Merz Organization.
What You Will Do
- Installed Base Support :Provide continuing product support for manufacturing, regulatory and quality on design requirements, customer needs, testing, CAPA, reliability predictions, and product documentation. 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.
Minimum Requirements
- Bachelor's Degree in Mechanical Engineering or equivalent experience or relevant engineering discipline
- Master of Engineering (M.Eng. or M.E.) in Mechanical
- 2-5 years ME or IE experience
- 2-5 years of related design / development or service experience in the medical device and/or component.
Technical & Functional Skills
- 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 Medical Devices.
- Knowledge and experience with field service.
- Excellent project management skills.
- 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!
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. Manufacturing Engineering
