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Manufacturing Engineer II - NPI

Date:  Jun 13, 2021
Location: 

Halethorpe, MD, US, 21227

Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,700 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.

 

Patients First | Innovation | Winning Culture | Heart Recovery
 

 

The Manufacturing Engineer II – NPI will support 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 support 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

  • Execute global product development production transfer efforts through recurring meeting coordination and travel between facilities.
  • Execute 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.
  • 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, while researching, defining and implementing new manufacturing technologies.
  • Assure the stable manufacturability of new products by supporting the design, qualification, optimization, and validation of processes and tooling via execution of IQ/OQ/PQ, gauge R&R studies, process capability studies and designs of experiments.
  • Utilize 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

 

Required Skills & Qualifications

  • Bachelors or Masters Degree in Mechanical or Manufacturing Engineering, or applicable scientific field (Advanced degree preferred)
  • 3+ years of relevant experience in Manufacturing Engineering, medical device experience strongly preferred
  • Familiarity with ISO regulations
  • Hands-on capabilities, with knowledge of manual & automated miniature component assembly techniques
  • Must be skilled in analysis, with experience using statistical tools and techniques

 

Preferred Skills & Qualifications

  • Familiarity with LEAN Manufacturing principles (certification preferred)
  • Familiarity with Six Sigma principles (Green Belt or higher preferred)
  • Experience developing products under FDA control preferred

 

 

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.


Nearest Major Market: Baltimore