Senior Supplier Process Engineer, Electronics

Johnson & Johnson - Danvers, MA

Full-time - Senior

Danvers, MA

Chemical Manufacturing

About the position

Abiomed, a part of Johnson & Johnson Medtech, is currently seeking a Senior Supplier Engineer, Electronics to be based in Danvers, MA. This role is pivotal in ensuring the quality and efficiency of electronic components and custom assemblies supplied to the company. The Senior Supplier Engineer will serve as the primary technical contact with all US-based suppliers, leading product development teams' supplier initiatives and establishing 'Quality at the Source' programs with key partners. This position is an excellent opportunity for someone looking to make a significant impact in the medical technology field, particularly in heart recovery solutions. In this role, the Senior Supplier Engineer will be responsible for managing engineering projects with suppliers, which includes conducting process validations, performing failure analysis, and mitigating component obsolescence. The engineer will partner with suppliers' engineering teams to analyze manufacturing processes, develop yield improvement project plans, and assess risks through Failure Mode and Effects Analysis (FMEA). Additionally, the engineer will work closely with internal design teams to evaluate product lifecycle changes and execute qualification test plans. The Senior Supplier Engineer will also act as a liaison for product development projects, ensuring effective communication and collaboration between suppliers and internal teams. This position requires a strong focus on Design for Manufacturing (DFM) improvements and the ability to influence development teams by representing supplier capabilities. The role is crucial for the company's growth and success in delivering innovative heart care solutions.

Responsibilities

• Act as the primary technical point of contact with suppliers who provide electronic components and custom assemblies.
• Lead frequently recurring meetings with suppliers to manage engineering projects, including process validations and failure analysis.
• Partner with supplier's engineering teams to analyze manufacturing processes and develop yield improvement project plans.
• Perform process constraints analysis and develop capacity increase plans based on Abiomed delivery forecasting.
• Assess risk through FMEAs and develop process validation plans to be executed at suppliers.
• Partner with internal design teams to assess product lifecycle design changes and develop qualification test plans.
• Act as a technical partner with internal inspection teams to assess defects and manage non-conformance investigations.
• Use project management tools to set milestone targets with suppliers and track deliverables.
• Support product development projects as a liaison responsible for supplier interactions and deliverables.
• Influence development team by representing capabilities of the supplier and push for DFM improvements at the design phase.
• Provide input on second source selection and qualify processes at second source suppliers.

Requirements

• Bachelor's degree required (master's degree preferred) in mechanical engineering, manufacturing engineering or related field.
• 5+ years experience in a professional field, preferably at a manufacturer who designs, manufactures and/or assembles electrical components, PCBs or consoles/box builds.
• Working knowledge of circuit board manufacturing and electrical component and assembly design theory.
• Knowledge of the process flow for ordering, receiving and using custom direct materials, including generating inspection plans and participating in MRB investigations.
• Demonstrated experience developing process validation plans, including IQ/OQ/PQ protocols/reports.
• Experience designing and executing Gauge R&R studies preferred.
• Demonstrated experience with root cause investigation and validation.
• Knowledge of statistical process control, including run charts and setting control limits.
• Basic metrology skills, including experience with calipers and vision systems.
• Working knowledge of project management fundamentals, including schedule and stakeholder management.
• Working knowledge of Microsoft Office Suite.
• Knowledge of FDA 21CFR820/821 and ISO 13485 requirements.
• Working knowledge of SAP is a plus.
• Willingness to travel up to 20% within the United States.

Nice-to-haves

• Lean Six Sigma Green Belt or Black Belt preferred.
• Experience with Gauge R&R studies.