Supplier Process Development Engineer II (1 of 2)

Abiomed, a part of Johnson & Johnson MedTech, is currently recruiting for a Supplier Process Engineer to be located in Danvers, MA.

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https : / / www.jnj.com / . ABIOMED is redefining team-driven success while reshaping heart recovery.

Here, new ideas are welcomed and encouraged, learning is constant, and our dynamic setting enables positive people to do profoundly important work.

If you have : the ability to build and grow strategic partnerships, a keen focus on consistency of methods and moving the company forward, and the desire to make a true impact on patient health, we want to hear from you.

Discover your true potential as you work with Suppliers, Manufacturing and Design teams, develop professionally, and contribute to a company imagining the future of heart care.

The Supplier Process Engineer serves as ABIOMED's primary technical contact with US based suppliers, leads product development team's supplier initiatives, second source critical suppliers, and establishes "Quality at the Source" programs with key partners.

This role is a key technical resource for the company's continued growth, and is a great opportunity for someone to make a difference at one of the fastest-growing medical technology companies, focused on recovering hearts and saving lives.

Principal Duties and Responsibilities :

• Outsource and transfer sub-assemblies from internal production to suppliers
• Act as the primary and / or support to the primary technical point of contact with suppliers who assemble mechanical and / or electro mechanical assemblies
• Partner with supplier's engineering teams to analyze manufacturing processes and use data to develop and execute yield improvement project plans
• Partner with supplier's engineering teams to perform process constraints analysis and develop capacity increase plans based on Abiomed delivery forecasting
• Use project management tools to set milestone targets with suppliers and track and report out on deliverables
• Partner with supplier's engineering teams to develop inspection methods and validate through GR&R
• Assess risk through FMEAs and develop process validation plans (MVP, IQ / OQ / PQ) to be executed at supplier
• Partner with internal design teams to assess product lifecycle design changes and develop and execute qualification test plans
• Act as a technical partner with internal incoming inspection teams to assess defects and manage non-conformance investigations
• Provide input on second source selection and qualify processes at second source suppliers
• Bachelors degree in mechanical engineering, manufacturing engineering or related
• 3 years experience in professional field required
• Knowledge of component assembly processes including gluing, press / snap fits, hot jaw bonding, chemical bonding, ultrasonic welding
• Demonstrated experience working on a manufacturing floor, with hands on ownership of processes / equipment development / improvement, operator interactions, non-conformance management and an understanding of the value chain
• Demonstrated experience developing process validation plans, including IQ / OQ / PQ protocols and reports
• Demonstrated experience performing Gauge R&R studies
• Demonstrated experience performing ranging studies / DOE to optimize processes
• Experience performing root cause investigations
• Knowledge of statistical process control tools
• Knowledge of basic metrology tools
• Experience small scope project management, including developing timelines and milestones, and managing stakeholders
• Working knowledge of Microsoft Office Suite
• Knowledge of FDA 21CFR820 / 821 and ISO 13485 requirements
• Working knowledge of SAP a plus
• Green Belt certified with proven classroom / project completion a plus
• Willingness to travel up to 20% within the United States Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.