Biomedical Engineer - Mechanical

Merz North America - Caledonia, WI

Full-time - Entry Level

Caledonia, WI

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About the position

The position at Merz Aesthetics involves providing ongoing support for product design and serviceability in the medical aesthetics sector. The role focuses on ensuring compliance with regulatory standards, supporting engineering teams in design and testing processes, and implementing continuous improvement methodologies. The candidate will play a crucial role in maintaining quality standards and supporting the Engineering Change Order process.

Responsibilities

• 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.
• Support the Engineering Change Order (ECO) process per Design Controls - Design Change regulations and internal policies.
• Develop and implement continuous improvement against current service methodologies.
• Ensure compliance with ISO 13485 standards, FDA regulations, and Good Manufacturing Processes regarding service and repair of new product launches and product upgrades.

Requirements

• Bachelor's degree in Mechanical Engineering or equivalent experience in a relevant engineering discipline.
• Master's degree in Mechanical Engineering is required.
• 2-5 years of Mechanical Engineering experience is required.
• 2-5 years of related design/development or service experience in the medical device and/or component industry is required.
• Knowledge of FDA Design Controls and EU Medical Device Directive (CE Marking requirements).
• Experience with Six Sigma statistical analysis and controls.
• Understanding of Ultrasound technology.
• Excellent project management skills.
• Previous experience in field service or service operations is required.

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
• Benefits and PTO start on the date of hire with no waiting period.