manufacturing Engineer

Position: Sr. Manufacturing Engineer

Location: Cambridge, MA

Job Description

The Sr. Manufacturing Engineer will work closely with R&D, Pilot, and commercial manufacturing teams, contributing to the product lifecycle from Early Human Use to commercialization. Responsibilities include ensuring design and manufacturing processes are well-characterized, robust, scalable, compliant with regulatory requirements, and validated for design control and manufacturing using LEAN Six Sigma and DFM methodologies. The role involves acting as a liaison among R&D, Supplier Development, Quality, and Operations teams.

Responsibilities

• Develop and optimize efficient, cost-effective, and validated manufacturing processes for medical devices, focusing on capital and/or disposable devices, including assembly, lot release testing, sterilization, and packaging.
• Produce production-level assembly and part drawings for all components and sub-assemblies.
• Incorporate Design for Manufacturing (DFM), Six Sigma, and LEAN principles into product and process designs to ensure manufacturability, minimize costs, and achieve optimal production efficiency through activities like DFMA reviews and cycle time optimization.
• Identify and evaluate potential contract manufacturing partners by analyzing quality, cost, delivery timelines, and regulatory compliance capabilities to recommend optimal providers.
• Lead and collaborate with contract manufacturers in selecting and developing the most efficient and reliable manufacturing processes and sites while fostering strong partnerships.
• Act as the liaison between Contract Manufacturing Organization (CMO) and Canon to coordinate manufacturing activities as directed by management.
  
  

Key Requirements

• Education: BS Degree
• Experience: 4+ years in medical device manufacturing
• Skills: Design Transfer to production, DFM (Design for Manufacturing), SolidWorks, process validation, experience with complex electro-mechanical systems