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.

This role serves as ABIOMED's primary technical contact with all US based suppliers, leads all 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 metal components.

• 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.

• 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.

• Use project management tools to set milestone targets with suppliers and track and report out on 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 (Design for Manufacturing) improvements at the design phase.

• Provide input on second source selection and qualify processes at second source suppliers.

Qualifications

• 3+ years experience in professional field

• Knowledge of Swiss Screw machining capabilities, precision milling, reaming, drilling, grinding, EDM, laser cutting, electropolishing, tumble/abrasion deburring, laser welding

• Demonstrated experience working at a manufacturer who designs, manufactures and/or assembles components with micron level tolerances and are made from high performance materials, including stainless steels, titanium, ceramics, kanthal, and/or nitinol

• Knowledge of the process flow for ordering, receiving and using custom direct materials; this includes generating incoming inspection plans, participating in MRB investigations, non-conformance generation and disposition, and management of product through ERP systems (SAP preferred)

• Demonstrated experience working on a manufacturing floor with hands on ownership of processes/equipment development/improvement, operator interactions, non-conformance management.

• 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.

• Demonstrated experience with root cause investigation, including the ability to validate root cause by turning off and on the failure

• Knowledge of statistical process control, including run charts, IM-R charts, setting control limits and keeping a process in a state of control

• Basic metrology skills, including experience with calipers, gauge pins, vision system/optical comparator.

• 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

• Willingness to travel up to 20% within the United States

The anticipated base pay range for this position is 77,000 to 124,200. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

• Holiday pay, including Floating Holidays - up to 13 days per calendar year

• Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

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