Senior Medical Device Manufacturing Engineer (Lean/DFMA)

JM Chandler Dream Builders; Cambridge (MA); On-site; USD 90,000 - 140,000; Full time

Job summary

Canon USA Boston Incubation Center seeks a Senior Manufacturing Engineer for medical devices to connect R&D with pilot and production manufacturing. Expect collaboration across QA, regulatory, suppliers, and operations, ensuring robust, compliant processes from development through commercialization.

The role emphasizes design transfer, process validation, and applying Lean Six Sigma to drive cost efficiency and quality across device families.

Qualifications

• Bachelor's degree in mechanical engineering or higher.
• 5+ years in medical device manufacturing engineering with NPD, design transfer, and process validation.
• Proficient in SolidWorks for complex assemblies.
• Experience with contract manufacturers and capital equipment.
• Strong knowledge of DFM, Six Sigma, LEAN, cGMP, and process validation.

Responsibilities

• Develop and optimize manufacturing processes for medical devices, including assembly, testing, sterilization, and packaging.
• Produce production-level drawings for components and sub-assemblies.
• Apply DFM, Six Sigma, and LEAN to ensure manufacturability and cost efficiency.
• Collaborate with contract manufacturers and CMOs to select and develop processes and sites.
• Coordinate design transfer and ensure regulatory alignment with Canon standards.
• Review specifications and CAD data for design reviews and BOM accuracy.
• Lead PMs for validation protocols, CPQ tests, and data analyses.
• Create and maintain work instructions, travelers, and documentation controls.

Skills

Design for Manufacturing (DFM)

Six Sigma

LEAN

Process Validation

Design transfer

cGMP

Regulatory compliance

Statistical analysis

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

MS Office Suite

Minitab/JMP

Job description

Canon USA Boston Incubation Center seeks a Senior Manufacturing Engineer for medical devices to connect R&D with pilot and production manufacturing. Expect collaboration across QA, regulatory, suppliers, and operations, ensuring robust, compliant processes from development through commercialization.

The role emphasizes design transfer, process validation, and applying Lean Six Sigma to drive cost efficiency and quality across device families.