Sr Supplier Process Engineer I- Assembly

re 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.

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 Sr 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:
• Act as the primary technical point of contact with suppliers who provide custom injection molded or extrusion components and/or multi-component sub-assemblies
• Lead efforts at suppliers to drive them for continuous improvement activities leading to yield and quality improvements using data driven approach and Lean Six Sigma methodologies
• Drive suppliers to perform process constraints analysis and develop capacity increase plans based on Abiomed delivery forecasting using a risk-based approach
• Engage with design engineers at early stages of development projects to review specifications and drawings; suggest and evaluate different potential manufacturing methods
• Utilize project management tools and skills to set milestone targets with suppliers and track and report out on deliverables
• Collaborate with internal cross functional teams and suppliers to determine qualification deliverables including: Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis while offering appropriate support where needed.
• Act as a technical partner with internal incoming inspection teams to assess non-conformances and collaborate with suppliers to perform root cause investigations
• Support product development projects as a liaison responsible for supplier interactions and deliverables
• Perform DFM activities by engaging suppliers early in development cycle to provide feedback for manufacturability improvements in the designs prior to production
• Lead and manage supplier change notifications including but not limited to equipment, process or design changes
• Collaborate with sourcing and development teams to determine criteria for supplier selection and supplier evaluation for new or second source projects
• Provide mentorship and guidance to junior engineers on the team

Qualifications

• Bachelors in mechanical engineering, manufacturing engineering, plastics engineering, or related disciplines required, Masters preferred
• 5+ years experience in professional field, medical device experience preferred
• Demonstrated experience designing, improving or supporting manufacturing of injection molded and/or extruded plastics components
• Knowledge of component assembly processes including gluing, press/snap fits, hot jaw bonding, chemical bonding
• Experience with conducting equipment and process validations
• Proven knowledge of Lean Manufacturing and Six Sigma methodologies.
• Excellent problem-solving skills and a data-driven approach to decision-making.
• Basic metrology skills, experience with calipers, gauge pins, vision system/optical comparator
• Ability to prioritize & complete tasks effectively to meet deadlines.
• Working knowledge of Microsoft Office Suite, Analytical softwares like Minitab
• Willingness to travel up to 25% 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.