Abiomed is looking for an experienced New Product Introduction (NPI) Senior Manufacturing Engineeringwho will contribute and potentially lead a team of Manufacturing Engineers whose mission is to ensure a smooth and timely transition of new products from feasibility into stable production.
Principle Duties and Responsibilities:
Mentor team in areas of engineering expertise, constantly moving the team towards improvements in technical skills and system knowledge.
Function spans from the early development process to stable production, influencing the product and process specifications to achieve the best quality, cost and cycle time.
Lead design for manufacturing (DFM) reviews to ensure producibility, inspectability, testability, maintainability and repairability.
Manage 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 closely with design engineering and supplier 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.
Work in cross-functional teams that span global operations.
Bachelors or Masters Degree in Mechanical or Manufacturing Engineering with a mechanical systems emphasis. Masters degree in a relevant discipline a plus
10+ years relevant experience in Manufacturing Engineering (medical device experience preferred).
Expertise in: complex mechanical systems assembly, 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.
Working leader and influencer in prior roles
Ability to work well in global team environment with excellent written and verbal communication skills.
Skills/experience with statistics, statistical tools/techniques.
Be able to travel up to 25% – US & EU
LEAN Manufacturing certification and proven track record of implementation
Six Sigma Green Belt (Black Belt preferred) certification
State or Province