Biomedical Engineer II - Mechanical

Merz North America • Racine, WI

72d

About The Position

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. An engineer, with a mechanical engineering foundation, having at least 5 years of experience developing and sustaining regulated electro-mechanical device design and process, to support the Ultherapy medical device product portfolio.

Requirements

• Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, or relevant engineering discipline.
• 3-5 years Mechanical Engineering experience.
• 3-5 years Related design or development experience in the medical device or other highly regulated industry (e.g., automotive).

Nice To Haves

• Master's Degree in Mechanical Engineering, Biomedical Engineering, or relevant engineering discipline.
• Skilled at using common electronics design tools such as T&M equipment, CAD tools, and simulation (e.g., SolidWorks).
• Test of electro-mechanical and/or electrical system in a production environment.
• Ability to articulate complex ideas to technical and non-technical personnel.
• Strong technical and problem-solving skills.
• Ability to formulate program strategy, budgets, and timelines.
• 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).
• Excellent project management skills, familiar with project management methods and tools.
• Familiar with electro-mechanical manufacturing, depot service, and field service processes and operations.
• Experience with system level requirements definition.
• Understanding of Ultrasound.
• Six Sigma Green Belt or higher a plus.

Responsibilities

• Lead and manage activities related to maintaining and improving 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 CAPA.
• 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.
• Work closely with cross-functional teams, including mechanical engineers, process engineers, quality, and regulatory, to ensure device safety, compliance, compatibility, functionality, manufacturability, and serviceability.
• Mentor junior engineers.
• Ensure that device complies with relevant regulations and standards (e.g., FDA, CE Mark, IEC 60601 series, ISO 13485, GMP).
• Develop detailed mechanical drawings.
• Document design processes and test results.
• Execute the Engineering Change Order (ECO) process per Design Controls - Design Change regulations and internal policies.
• Support regulatory submissions.

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
• Your benefits and PTO start the date you're hired with no waiting period!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Wholesale Trade Agents and Brokers
• Education Level: Bachelor's degree