Biomedical Engineer - Electrical

Merz North America - Caledonia, WI

Full-time - Mid Level

Caledonia, WI

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About the position

The position at Merz Aesthetics focuses on providing comprehensive support for product design and serviceability in the medical device sector. The role involves collaboration with engineering teams to ensure compliance with regulatory standards, enhance service methodologies, and maintain product quality throughout its lifecycle. The candidate will play a crucial role in supporting manufacturing, regulatory, and quality aspects of product development, ensuring that all design requirements and customer needs are met effectively.

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

Requirements

• Bachelor's in electrical engineering or relevant engineering discipline.
• Master's in electrical engineering.
• 3-5 years of EE experience.
• 3-5 years of related design/development or service experience in the medical device and/or component.

Nice-to-haves

• Experience with FDA Design Controls and EU Medical Device Directive (CE Marking requirements).
• High level of experience with system level requirements definition.
• PCB Design and Analysis experience and understanding, grounding / EMI considerations.
• Understanding of Ultrasound.
• Knowledge and experience with field service.
• Familiarity with common electronics design tools such as T&M equipment, CAD tools, and simulation.
• Excellent project management skills.
• Knowledge and understanding of RF circuitry.
• 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!