NPI Operations Project Lead

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!

Job Title: NPI Operations Project Leads

Job Location: 22 Cherry Hill Drive, Danvers, MA 01923

Send resumes to: Abiomed, Inc. 22 Cherry Hill Drive, Danvers, MA 01923 (Attn: REQ #20333) or apply online at https://careers.abiomed.com.

Employer: Abiomed, Inc. 22 Cherry Hill Drive, Danvers, MA 01923

Job Duties:

The NPI Operations Project Lead will be responsible for planning and implementation of new product changes into production in collaboration with development and operations. The position 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.

Principal Responsibilities and Duties:

1. Lead transfer of new products, design changes and processes into production in collaboration with development and operations team;
2. Influence design specifications to achieve the best quality, cost, yield, and cycle time such that business goals and objectives are met;
3. Create manufacturing strategies with input from stakeholders and the project core team to support product qualification and validation builds;
4. Develop and qualify manufacturing processes and tooling via IQ/OQ/PQ, gauge R&R studies, and process capability studies by partnering with process engineering team;
5. Develop process documentation (assembly procedures, test procedures, routers, travelers, process flows, and process FMEAs) in conjunction with operations team;
6. Communicate project status, schedule progress and key project metrics through standardized best practices;
7. Identify and establish Lean manufacturing methods, processes, and tools for new products and establish process controls and opportunities for mistake-proofing of products and processes; and
8. Support and enforce company goals and objectives, policies and procedures, Good Manufacturing Practices, Good Documentation Practices, FDA QSR and ISO regulations.

Telecommuting may be permitted, so long as the employee is based in the Danvers, MA region, as the employee must conduct regular visits to company offices in the Danvers, MA region.

Requires 5% domestic travel per year and 20% international travel per year.

Education, Experience and Skills Requirements:

Employer requires candidate to have a Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or a closely related field and at least five (5) years of progressively more responsible work experience in a manufacturing environment.

Alternatively, the employer will accept a Master's degree in Mechanical Engineering, Manufacturing Engineering, or a closely related field and at least three (3) years of progressively more responsible work experience in a manufacturing environment.

Candidate must also have the following:

• Demonstrated ability with project management gained through at least three (3) years of work experience;
• Demonstrated ability working in a global cross-functional team environment gained through at least three (3) years of work experience;
• Demonstrated knowledge of manual manufacturing processes gained through at least three (3) years of work experience; and
• Demonstrated knowledge of statistics, statistical tools, and techniques gained through at least three (3) years of work experience.

All years of experience may be gained concurrently.

This position is eligible for Abiomed's Employee Referral Program

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.