Manufacturing Design Engineer Job at FlairwWorks Consulting LLC in Cambridge

Job Title: Medical Device Senior Manufacturing Engineer
Work Hours: 35 hours/week (7 hours/day)

Job Description:
We are seeking a Sr. Manufacturing Engineer to join our client’s Boston Incubation Center, collaborating with hospitals to turn cutting-edge medical research into commercial products. This role involves developing and optimizing manufacturing processes for medical devices, ensuring robust, scalable solutions that meet regulatory requirements. The Senior Engineer will work across R&D, Pilot, and commercial manufacturing teams, focusing on product design, process validation, and manufacturing efficiency.

Key Responsibilities:

• Develop and optimize manufacturing processes for medical devices, including assembly, sterilization, and packaging.
• Produce detailed part and assembly drawings, and ensure compliance with manufacturing standards.
• Implement DFM, Six Sigma, and LEAN principles to ensure manufacturability and efficiency.
• Work with contract manufacturers to select and develop efficient manufacturing processes.
• Lead risk assessments, process validation, and continuous improvement initiatives.
• Collaborate with cross-functional teams, ensuring successful design transfer and commercialization.

Must Have:

• Bachelor's degree in Mechanical Engineering.
• 5+ years of experience in medical device manufacturing, including 3+ years in new product development and design transfer.
• Hands-on experience with cart systems, console operations, and electromechanical devices.
• Proficiency in SolidWorks and experience with assemblies containing multiple parts.
• Strong knowledge of DFM, Six Sigma, LEAN, cGMP, and process validation.
• Experience with contract manufacturers/vendors in capital equipment or electronics testing.

Nice to Have:

• Lean and/or Six Sigma certifications.