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. Proactively 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.
Job Responsibilities
Develop and optimize manufacturing processes for medical devices.
Produce assembly and part drawings for components and sub-assemblies.
Incorporate DFM, Six Sigma, and LEAN principles into designs.
Identify and evaluate potential contract manufacturing partners.
Lead collaboration with contract manufacturers.
Act as liaison between CMO and Canon.
Education & Experience
BS Degree
5+ years of medical device manufacturing experience is a big plus
Skills
Design Transfer to production
DFM (Design for Manufacturing)
SolidWorks
Process validation
Catheter experience
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering and Information Technology
Industries
Staffing and Recruiting
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