NPI Engineer I 7/22/2018

ABIOMED Inc. Danvers, MA

Danvers, MA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)
Bachelors Degree


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.

The NPI Engineer I 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.

Principal Duties and Responsibilities:

* Support global new product development from a manufacturing perspective

* Influence the product specification to achieve the best quality, cost and cycle time

* Partner with Product Development team to ensure that products under development are designed for manufacture, test, and inspection as appropriate.

* Qualify, optimize, and validate processes and tooling (IQ/OQ/PQ, gauge R&R studies, process capability studies, 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.

* Maintain accurate documentation of concepts, designs, and processes while maintaining current knowledge of medical, technical, and biomedical developments as related to Abiomed products.

Job Qualifications:

* BS in engineering required, MS desired

* 0-2 years of related work experience in Manufacturing Engineering or New Product Introduction desired, preferably in medical device industry

* Knowledge of QSR and ISO regulations and knowledge of FDA regulations is desirable

* Knowledge of Six Sigma and Lean Manufacturing tools is desirable

* Must be willing and able to travel internationally (10-25%) in support of this role s responsibilities and duties

* Technical skills: 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.