Supplier Process Engineer

Johnson & Johnson - Danvers, MA

Full-time - Mid Level

Danvers, MA

Chemical Manufacturing

About the position

The Supplier Process Engineer at Abiomed will serve as the primary technical contact with US-based suppliers, focusing on enhancing manufacturing processes and ensuring quality in custom metal components. This role involves collaboration with supplier engineering teams to analyze and improve yield, develop inspection methods, and manage product lifecycle changes. The position is crucial for supporting product development initiatives and driving improvements in design for manufacturing, ultimately contributing to the company's mission of advancing heart recovery technologies.

Responsibilities

• Act as the primary technical point of contact with suppliers who provide custom metal components.
• 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.
• Develop inspection methods and validate through Gauge R&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 qualification test plans.
• Act as a technical partner with internal incoming 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 supplier capabilities and advocating for DFM improvements.
• Provide input on second source selection and qualify processes at second source suppliers.

Requirements

• 3+ years experience in a professional field.
• Knowledge of Swiss Screw machining capabilities, precision milling, reaming, drilling, grinding, EDM, laser cutting, electropolishing, tumble/abrasion deburring, laser welding.
• Experience working at a manufacturer designing, manufacturing, and/or assembling components with micron level tolerances from high performance materials.
• Knowledge of the process flow for ordering, receiving, and using custom direct materials, including generating incoming inspection plans and managing product through ERP systems (SAP preferred).
• Experience developing process validation plans, including IQ/OQ/PQ protocols and reports.
• Experience performing Gauge R&R studies and ranging studies/DOE to optimize processes.
• Experience with root cause investigation and validating root causes by manipulating failure conditions.
• Knowledge of statistical process control and basic metrology skills.
• Knowledge of project management fundamentals and working knowledge of Microsoft Office Suite.
• Knowledge of FDA 21CFR820/821 and ISO 13485 requirements.

Nice-to-haves

• Experience with medical device manufacturing processes.
• Familiarity with advanced manufacturing technologies and techniques.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Short- and long-term disability insurance
• Business accident insurance
• Group legal insurance
• 401(k) retirement plan
• Vacation time (up to 120 hours per year)
• Sick time (up to 40 hours per year)
• Holiday pay (up to 13 days per year)
• Work, Personal and Family Time (up to 40 hours per year)