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.

Deliverables:

• 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.