Senior Manufacturing Engineer – Medical Devices, Cambridge MA - Confidential

Location: Cambridge, MA (On-site)
Employment Type: Full-Time (35 hours per week)

Job Summary:
Our client seeks a highly skilled Senior Manufacturing Engineer with hands-on expertise in cart systems, console operations, and electromechanical devices. This role involves collaboration between R&D, pilot, and commercial manufacturing teams, contributing from Early Human Use to product commercialization. The ideal candidate will ensure robust and scalable design and manufacturing processes utilizing Lean Six Sigma, Design for Manufacturing (DFM), and Design for Cost methodologies.

Key Responsibilities:

• Develop and optimize cost-effective, validated manufacturing processes for medical devices, including assembly, testing, sterilization, and packaging.
• Create production-level assembly and part drawings for components and sub-assemblies.
• Integrate DFM, Six Sigma, and LEAN principles into designs to enhance manufacturability and reduce costs.
• Identify and evaluate contract manufacturing partners for quality, cost, and regulatory compliance, and foster partnerships with selected providers.
• Act as a liaison between Contract Manufacturing Organizations (CMOs) and the client to coordinate manufacturing activities.
• Review engineering specifications and CAD drawings to ensure compliance with industry and manufacturing standards.
• Maintain accuracy of part/drawing releases and Bill of Materials (BOM).
• Lead process validation activities, including writing and executing protocols and reports.
• Deploy manufacturing risk assessments and mitigation strategies.
• Develop and maintain manufacturing work instructions and equipment guidelines under quality management system controls.
• Provide expertise in pFMEA, process validation, Lean Six Sigma, and design transfer.

Results Expected:

• Maintain up-to-date BOMs, work instructions, and process travelers.
• Create and maintain comprehensive pFMEAs.
• Develop project task lists for DFM activities.

Qualifications:

• Bachelor’s degree or higher in Mechanical Engineering.
• Minimum of 5 years of medical device manufacturing engineering experience, including 3 years in new product development and process validation.
• Strong modeling and drawing skills in SolidWorks, particularly with assemblies containing dozens of parts.
• Experience with contract manufacturers/vendors for capital equipment and electronics testing is strongly preferred.
• Proven expertise in DFM, Six Sigma, LEAN, cGMP, and process validation.
• Proficient in statistical analysis tools such as Minitab or JMP for process improvement.
• Highly proficient in Microsoft Office Suite.

Preferred Qualifications:

• Lean and/or Six Sigma certifications.

This role offers a unique opportunity to shape innovative medical devices from design to commercialization. If you are a detail-oriented engineer with a passion for improving manufacturing processes, apply today to make an impact!

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