Senior Manufacturing Engineer Medical Device

Right Hire Consulting LLC; Cambridge (MA); Vor Ort; USD 120.000 - 170.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

DFM

Six Sigma

LEAN

cGMP

Sterilizable polymers

Ausbildung

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

Minitab

JMP

MS Office

Jobbeschreibung

Senior Manufacturing Engineer Medical Device

About the job Senior Manufacturing Engineer Medical Device

The Senior Manufacturing Engineer plays a key role in bridging R&D, pilot, and commercial manufacturing for medical devices, ensuring robust and scalable manufacturing processes from early development to commercialization. The role emphasizes efficiency, quality, regulatory compliance, and cost-effectiveness while collaborating across departments and with contract manufacturers.

Key Responsibilities:

• Develop and validate efficient, cost-effective manufacturing processes for medical devices, including assembly, testing, sterilization, and packaging.
• Create production-level drawings and optimize designs for manufacturability (DFM), cost, and efficiency using Six Sigma and LEAN principles.
• Identify, evaluate, and collaborate with contract manufacturers, ensuring quality, cost, and regulatory compliance.
• Act as a liaison between internal teams and contract manufacturers to coordinate manufacturing activities.
• Review engineering specifications and CAD drawings to ensure compliance with standards and best practices.
• Manage part/drawing releases and ensure accuracy of Bills of Materials (BOMs).
• Plan and execute process characterization and validation, including risk assessments and critical control point identification.
• Develop and maintain manufacturing documentation, including work instructions, equipment guides, and process validations.
• Lead or contribute to pFMEA and implement Lean Six Sigma methodologies.
• Collaborate with cross-functional teams, including engineers, quality specialists, regulatory experts, and suppliers, to achieve project objectives.
• Up-to-date and accurate BOMs, work instructions, and process documentation.
• Comprehensive pFMEA and validated manufacturing processes.
• Effective coordination with contract manufacturers and stakeholders.

Qualifications:

• Bachelors degree or higher in Mechanical Engineering.
• 5+ years of experience in medical device manufacturing, including new product development, design transfer, and process validation.
• Proficiency in SolidWorks for modeling and fixture/tool design.
• Experience with contract manufacturers, especially in capital equipment or catheter manufacturing.
• Strong knowledge of DFM, Six Sigma, LEAN, cGMP, and sterilizable polymers.
• Proficiency in Microsoft Office and statistical software like Minitab or JMP.

Preferred Skills:

• Lean and/or Six Sigma certifications.
• Expertise in catheter fabrication techniques and electronics testing processes.

This position offers the opportunity to work on innovative medical technologies in a highly collaborative environment.