Abiomed, an innovative medical device company, is focused on recovering hearts and saving lives. We have a single guiding mission: “Patients First.” With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,000 employees form one of the fastest growing medical technology companies in the world. Abiomed attracts and retains exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.
JOB DESCRIPTION
The New Product Introduction (NPI) Program Manager will oversee the design, development, improvement and validation of manufacturing processes, tooling, and fixtures in order to meet manufacturability requirements for new and existing products. They will Lead the transition of new products and approaches into production by pushing design for manufacturability early in the design phase, and pulling product into production when the design is complete.
KEY RESPONSIBILITIES
Lead global product development production transfer efforts through recurring meeting coordination and travel between facilities.
Lead prototype, V+V, pilot and commercial production of new products, product changes, and enhancements in coordination with the Product Development, Manufacturing, Supply Chain and Quality Assurance organizations.
Create the manufacturing strategy, with input from stakeholders, and the project core team to ensure timely completion in line with phase gate reviews.
Influence the product specification to achieve the best quality, cost, yield and cycle time such that corporate objectives are met in a timely manner.
Partner with product development staff to ensure that products under development are designed for assembly, test, and inspection by application of best practices with NPI and DFM checklists.
Plan production transfer effort, estimating required timing, risks, resources and budgets which are consistent with corporate objectives.
Communicate project status, schedule progress and key project metrics through scorecard presentations, action items and meeting minutes, and manufacturing readiness reviews with core team and senior management.
Develop process documentation (assembly procedures, test procedures, routers, travelers, BOMs, process flows, and process FMEAs) in conjunction with production engineering, while researching, defining and implementing new manufacturing technologies.
Assure the stable manufacturability of new products by overseeing the design, qualification, optimization, and validation of processes and tooling via IQ/OQ/PQ, gauge R&R studies, process capability studies and designs of experiments.
Define and Establish Lean manufacturing methods, processes, and tools for new products. Establish process controls and opportunities for mistake-proofing.
Support and enforce company goals and objectives, policies and procedures, Good Manufacturing Practices, Good Documentation Practices, FDA QSR and ISO regulations.
This position will require up to 25% travel – US & Europe
Skills/Requirements
REQUIRED SKILLS / QUALIFICATIONS
Bachelors or Masters Degree in Mechanical or Manufacturing Engineering, or applicable scientific field (Advanced degree preferred)
5+ years of relevant experience in Manufacturing Engineering, medical device experience strongly preferred
Intimate knowledge of ISO regulations
Hands-on capabilities, with good knowledge of manual & automated miniature component assembly techniques
Must be skilled in analysis, with experience using statistical tools and techniques
Ability to work well in team environment with excellent written and verbal communication skills
Ability to travel internationally (Europe) up to 25% of the time in support of the position’s responsibilities
PREFERRED SKILLS / QUALIFICATIONS
LEAN Manufacturing certification and proven track record of implementation
Six Sigma Green Belt (Black Belt preferred) certification
Experience developing products under FDA control
ABIOMED is an Equal Employment Opportunity/Affirmative Action employer. We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, veteran status, disability or national origin.