Senior Medical Device Process & Validation Engineer

Right Hire Consulting LLC; Cambridge (MA); On-site; USD 120,000 - 170,000; Full time

Job summary

Right Hire Consulting LLC is seeking a Senior Manufacturing Engineer for medical devices to bridge R&D, pilot, and commercial manufacturing, delivering scalable processes from development to launch.

You will lead process development and validation, implement DFM and Six Sigma, collaborate with contract manufacturers, ensure cGMP compliance, and produce clear BOMs and documentation.

Qualifications

• Bachelors degree in Mechanical Engineering required.
• 5+ years of medical device manufacturing experience including NPD, design transfer, and validation.
• Proficiency in SolidWorks; contract manufacturers and capital equipment/catheter know-how.

Responsibilities

• Develop and validate manufacturing processes for medical devices, including assembly, testing, sterilization, and packaging.
• Create production drawings and optimize for manufacturability and cost using Six Sigma and LEAN.
• Collaborate with contract manufacturers to ensure quality, cost and regulatory compliance.
• Coordinate manufacturing activities between internal teams and external suppliers/CMs.
• Review specifications and CAD drawings for standards compliance.
• Manage BOMs and part/drawing releases.
• Plan process characterization and validation, including risk assessments and CCPs.
• Lead or contribute to pFMEA and maintain validated processes.

Skills

DFM

Six Sigma

LEAN

cGMP

Sterilizable polymers

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

Minitab

JMP

MS Office

Job description

Right Hire Consulting LLC is seeking a Senior Manufacturing Engineer for medical devices to bridge R&D, pilot, and commercial manufacturing, delivering scalable processes from development to launch.

You will lead process development and validation, implement DFM and Six Sigma, collaborate with contract manufacturers, ensure cGMP compliance, and produce clear BOMs and documentation.