Medical Device Manufacturing Innovation Lead

3 weeks ago

Cambridge, Massachusetts, United States JM Chandler Dream Builders Full time

About Canon USA's Boston Incubation Center

At Canon USA's Boston Incubation Center, we're pushing the boundaries of medical research to create innovative, life-changing products. We're collaborating with world-class hospitals in the Boston area to turn cutting-edge ideas into reality.

We're seeking an experienced Medical Device Manufacturing Innovation Lead to join our team. As a key member of our engineering team, you'll work closely with our R&D, Pilot, and commercial manufacturing teams to develop and implement efficient, cost-effective manufacturing processes for our medical devices.

The successful candidate will have a proven track record in design transfer, process validation, and knowledge of sterilizable polymers and catheter fabrication techniques. They'll also have expertise in Design for Manufacturing, Six Sigma, LEAN, cGMP, and process validation.

Key Responsibilities

• Develop and optimize manufacturing processes for medical devices, focusing on capital and disposable devices, including assembly, lot release testing, sterilization, and packaging.

• Produce production-level assembly and part drawings for all components and subassemblies.

• Incorporate Design for Manufacturing, Six Sigma, and LEAN principles into product and process designs to ensure manufacturability, minimize costs, and achieve optimal production efficiency.

• Identify and evaluate potential contract manufacturing partners, analyzing quality, cost, delivery timelines, and regulatory compliance capabilities.

• Lead and collaborate with contract manufacturers to select and develop efficient and reliable manufacturing processes and sites, fostering strong partnerships.

• Act as a liaison between Contract Manufacturing Organization (CMO) and Canon to coordinate manufacturing activities.

• Review engineering product specifications and CAD data/drawings to ensure they meet industry and manufacturing standards and practices.

Requirements

• Bachelor's degree in Mechanical Engineering or higher.

• 5 years of experience in medical device manufacturing engineering, including at least 3 years in new product development, design transfer to production, and validating processes.

• Excellent modeling and drawing skills using SolidWorks, including proficiency with assemblies containing dozens of parts.

• Experience working with contract manufacturers/vendors for capital equipment, electronics testing, and/or catheter manufacturing is strongly preferred.

Benefits

We offer a competitive salary and benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.

Location

The successful candidate will be based in the Boston area, with frequent travel to our incubation center and contract manufacturing partners.

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