Medical device manufacturing Cambridge MA

Sr. Manufacturing Engineer

Location: Boston, Massachusetts

Job Description:

• Collaborate with world-class hospitals to turn cutting-edge medical research into usable, meaningful products.
• High collaboration between R&D, Pilot, and commercial manufacturing for the commercialization of new products.
• Ensure design and manufacturing processes are robust, scalable, and compliant with regulatory requirements.
• Act as a liaison between R&D, Supplier Development, Quality, and Operations team members.

Key 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.
• Incorporate Design for Manufacturing (DFM), Six Sigma, and LEAN principles into product and process designs.
• Identify and evaluate potential contract manufacturing partners for optimal provider recommendations.
• Lead collaboration with contract manufacturers to develop efficient manufacturing processes.
• Coordinate manufacturing activities between the Contract Manufacturing Organization (CMO) and Canon.
• Review engineering product specifications and CAD data/drawings for industry and manufacturing standard compliance.
• Drive the development and execution of complex experiments and tests on product lines.
• Responsible for Characterization and Validation activities, including CTQ flow-down.
• Develop and maintain manufacturing work instructions and equipment instructions.
• Coordinate technical communications between Canon and contract manufacturers.
• Provide technical expertise in conducting pFMEA and developing process validations.

Results Expected:

• Development and maintenance of project task list for DFM Activities.
• Create and maintain up-to-date BOMs, work instructions, and travelers.
• Creation and maintenance of pFMEA.

Qualifications:

• Bachelor's degree or higher in Mechanical Engineering.
• 5+ years of experience in medical device manufacturing engineering, including new product development.
• Excellent modeling and drawing skills using SolidWorks.
• Experience working with contract manufacturers/vendors for capital equipment and electronics testing preferred.
• Proven track record in design transfer and process validation.
• Technical expertise in DFM, Six Sigma, LEAN, cGMP, and process validation.
• Proficient in Microsoft Office Suite and statistical analysis software like Minitab or JMP.

Nice to Haves:

• Lean and/or Six Sigma certifications preferred.