Senior Manufacturing Engineer Medical Devices

$135,200 - $135,200/Yr

Care Dynamics - Cambridge, MA

Full-time - Mid Level

Cambridge, MA

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About the position

The Senior Manufacturing Engineer for Medical Devices will be responsible for optimizing manufacturing processes and ensuring compliance with regulatory standards in the development of innovative medical devices. This hands-on role involves collaboration with R&D, pilot, and commercial manufacturing teams to bring products from concept to commercialization, focusing on both capital and disposable devices.

Responsibilities

• Develop and optimize efficient, cost-effective, and validated manufacturing processes for medical devices.
• Produce production-level assembly and part drawings for components and sub-assemblies using SolidWorks.
• Lead Design for Manufacturing (DFM) activities, ensuring product manufacturability and minimizing costs through Six Sigma and LEAN principles.
• Work with contract manufacturers, selecting and developing reliable manufacturing processes.
• Drive complex experiments and tests to validate manufacturing processes and ensure regulatory compliance.
• Develop and maintain project documentation, including BOMs, work instructions, and process validations.
• Coordinate technical communications between internal teams and contract manufacturers.

Requirements

• Bachelor's degree or higher in Mechanical Engineering.
• 5+ years of experience in medical device manufacturing, including 3+ years in new product development and design transfer.
• Hands-on experience with cart systems, console operations, and electromechanical devices.
• Proficiency in SolidWorks for designing assemblies, parts, and fixtures.
• Expertise in DFM, Six Sigma, LEAN, cGMP, and process validation.
• Experience working with contract manufacturers, especially in capital equipment and electronics testing.
• Strong knowledge of statistical analysis software such as Minitab or JMP.

Benefits

• Competitive hourly rate of $65 per hour
• Opportunity to work on advanced medical device projects with world-class hospitals
• Involvement in the full product lifecycle from development to commercialization
• Collaboration with cross-functional teams and top industry experts
• Hands-on experience with innovative medical technologies
• Work in a fast-paced, technology-driven environment
• 35-hour work week, with 7-hour workdays