Program Manager - NPI
Danvers, MA
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Job Description
Job Description:
The Program Manager for NPI will lead a team of Manufacturing Engineers to ensure the smooth and timely transition of new products from feasibility into stable production.
Principle Duties and Responsibilities:
- Organize the team around standardized best practices for project management, including schedule development, resource and budget estimates, requirements generation, cost/benefit analyses, design and development milestones, priority and task management, and meeting facilitation.
- Manage direct reports including establishing goals and objectives, prioritizing, assigning and directing work, and appraising performance.
- Mentor team in areas of engineering expertise, constantly moving the team towards improvements in technical skills and system knowledge.
- Work in cross-functional teams that span global operations.
- Contribute early in the development process, influencing the product specification to achieve the best quality, cost and cycle time.
- Lead design for manufacturing (DFM) reviews to ensure producibility, inspectability, testability, maintainability and repairability.
- Assist in prototype and pilot builds, document the build process with work instructions, define and implement new manufacturing technologies.
- Qualify and optimize processes and tooling via IQ/OQ/PQ, gauge R&R studies, process capability studies and designs of experiments.
- Partner with design engineering to develop supplier specifications with strong emphasis on DFM.
- Define and establish Lean manufacturing methods, processes, and tools for new products. Establish process controls and opportunities for Poka Yoke (mistake proofing of products and mistake proof processes).
Skills/Requirements
Skills/Requirements
- Bachelors or Masters Degree in Mechanical or Manufacturing Engineering or applicable scientific field.
- 10+ years relevant experience in Manufacturing Engineering (medical device experience preferred).
- Ability to work well in team environment with excellent written and verbal communication skills.
- Expertise in: polymer processing, mold design best practices, metrology, GR&R and GD&T.
- Hands on capability with good knowledge of manual and automated miniature component assembly techniques.
- Skills/experience with statistics, statistical tools/techniques.
- Desirable skills:
- LEAN Manufacturing certification and proven track record of implementation
- Six Sigma Green Belt (Black Belt preferred) certification
- Experience developing products under FDA control
- Position requires up to 25% travel – US & EU #LI-LG1