Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

I Am Abiomed | I Am Heart Recovery | Patients First!

The Sr. NPI Engineer I will facilitate 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 coordinate the transition of new products and approaches into production by pushing design for manufacturability early in the design phase and working cross-functionally to pull product into production when the design is complete.

KEY RESPONSIBILITIES

• Manage global product development production transfer efforts through recurring meeting coordination and travel between facilities.
• Manage prototype, V+V, pilot and commercial production of new products, product changes, and enhancements in coordination with the Product Development, Manufacturing, Supply Chain, Regulatory, and Quality Assurance organizations.
• 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.
• 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 & Quality, while researching, defining and implementing new manufacturing technologies.
• Assure the stable manufacturability of new products by driving 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 may require up to 25% travel – US & Europe

REQUIRED SKILLS / QUALIFICATIONS

• Bachelors Degree in Mechanical or Manufacturing Engineering, or applicable scientific field, Master's 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
• Ability to self-manage many competing priorities in an environment with multiple projects, deadlines, and stakeholders

PREFERRED SKILLS / QUALIFICATIONS

• Plastics and adhesives experience preferred, especially material selection, failure modes, and fabrication techniques
• 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 Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.