Job Description
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
An experienced engineer, with a device engineering foundation, having at least 7 years of experience developing and sustaining regulated electro-mechanical device design and process, to support the Ultherapy medical device product portfolio.
What You Will Do
- 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 troubleshooting activities, investigate the root cause to a successful conclusion, and help to resolve product complaints and CAPA. Provide alternatives to end of life for electrical components.
- 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.
- Leadership Mentor junior electrical engineers.
Minimum Requirements
- Bachelor's Degree in Electrical Engineering, Mechanical Engineering, other relevant Engineering discipline.
- 7+ years Electrical engineering experience in a heavily regulated industry (e.g., automotive, medical).
Preferred Qualifications
- Master of Engineering (M.Eng. or M.E.) Or other relevant Engineering discipline.
- Electrical engineering experience in the medical device industry.
Technical & Functional Skills
- Printed circuit board design and analysis experience and understanding.
- Experience with Altium Designer or other electrical PCB design software.
- Strong technical and problem-solving skills.
- Ability to communicate and write effectively.
- Emotional self-management in difficult situations.
- Understanding of process validation and statistical analysis.
- Understanding and application of ISO 13485 quality management system requirements.
- Understanding of FDA Design Controls and EU Medical Device Directive (CE Marking requirements).
- Familiar with electro-mechanical manufacturing, depot service, and field service processes and operations.
- Experience with system level requirements definition.
- Understanding of Ultrasound.
- Knowledge and understanding of RF circuitry.
- Experience with designing and implementing electrical solutions associated with cybersecurity standards and guidance for medical devices to meet regulatory requirements (e.g., UL 2900, TIR 57, FDA).
- Practical knowledge of Six Sigma methodologies. Green or Black Belt certification.
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 also valuing our employees.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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Job Tags
Full time,