The Sr. Manager, NPI Manufacturing Engineering, IDC is responsible for leading the efforts of multi-discipline Manufacturing Engineers in support of New Product Development and Sustaining Product design transfer to outsourced manufacturing partners
Job Summary
The Sr. Manager, NPI Manufacturing Engineering, IDC is responsible for leading the efforts of multi-discipline Manufacturing Engineers in support of New Product Development and Sustaining Product design transfer to outsourced manufacturing partners.
Ensures that Manufacturing Engineering teams deliver the highest quality products and documentation using processes which consistently meet (or exceed) all applicable customer expectations; follows QSRs, FDA and ISO requirements; abides by company safety policies, practices and procedures; and is compliant with the latest regulations, globally.
Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives.
Matching Summary
The Sr. Manager, NPI Manufacturing Engineering, IDC is responsible for leading the efforts of multi-discipline Manufacturing Engineers in support of New Product Development and Sustaining Product design transfer to outsourced manufacturing partners.
Skills & Requirements
Must-have
Manufacturing Engineering leadership
New Product Development support
Design transfer to manufacturing
Product release validation
Process development and implementation
Failure Modes and Effects Analysis (pFMEA)
Nice-to-have
Continuous improvement activities
Cross-functional team collaboration
Career growth and development
Innovative solutions development
Key Requirements
Bachelor's degree in Electrical or Mechanical Engineering
10+ years of progressive experience in medical device manufacturing engineering
3+ years of direct management experience in manufacturing operations
Proficiency with ERP systems (SAP or Oracle)
Hands-on experience with MES, LIMS, or equivalent platforms
Proven track record of compliance with FDA, ISO 13485
Experience in process validation and equipment qualification