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 NPI Engineer will design, develop, improve and validate manufacturing processes, tooling, and fixtures in order to meet manufacturability requirements for new and existing products and ensure the smooth and timely transition of new products from feasibility into stable production.
KEY RESPONSIBILITIES
Support global new product development and production transfer efforts through recurring meeting coordination/attendance and international travel (10% required) between facilities. Influence the product specification to achieve the best quality, cost 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 manufacture, test, and inspection as appropriate. Qualify, optimize, and validate processes and tooling via IQ/OQ/PQ, gauge R&R studies, process capability studies and designs of experiments.
Support prototype, V+V, pilot and commercial production of new products, product changes, and enhancements in coordination with the Operations, Product Development and Quality Assurance organizations.
Develop and maintain process documentation (assembly procedures, test procedures, routers, travelers, BOMs, process flows, and process FMEAs) while defining and implementing new manufacturing technologies.
Define and establish Lean manufacturing methods, processes, and tools for new products. Establish process controls and opportunities for mistake-proofing.
Plan and schedule small scale projects, estimating required timing, resources and budgets which are consistent with corporate objectives.
Regularly report on project status, schedule progress and key project metrics through scorecard presentations, action items and meeting minutes, and manufacturing readiness reviews with program and operations management.
Ability to work in cross-functional teams that span global operations. Highly effective communicator of technical status and issues required. Must enjoy team approach over individual contributions.
Support and enforce company goals and objectives, policies and procedures, Good Manufacturing Practices, Good Documentation Practices, FDA QSR and ISO regulations.
Maintain accurate documentation of concepts, designs, and processes while maintaining current knowledge of medical, technical, and biomedical developments as related to Abiomed products.
Skills/Requirements
QUALIFICATIONS
BS in engineering required, MS desired with a minimum of 2-3 years of related work experience desired. Medical device experience preferred.
Basic experience with requirements generation, cost/benefit analyses, design and development milestones, priority and task management, and meeting facilitation.
Intimate knowledge of ISO regulations required, intimate knowledge of FDA and QSR regulations strongly preferred.
Minimum of Six Sigma greenbelt (black belt desired) and Lean Manufacturing training/certification or equivalent required.
Internationaltravel (10%) required
Must be proficient in Microsoft Office Suite. Working knowledge of SAP desired.
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.
