About MedTech

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

About Cardiovascular

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Abiomed is an innovative medical device business with an inspiring mission "Patients First," and a unique guiding company principle " Recovering hearts. Saving lives." With more than 3,000 employees, Abiomed is one of the fastest growing medical technology businesses in the world with corporate headquarters in Danvers, USA, and locations in Aachen and Berlin, Germany, Tokyo, Japan, and Singapore. Abiomed is part of Johnson & Johnson MedTech.

Abiomed is an employer with attractive working conditions and an appreciative corporate culture that focuses on the needs of its employees. Abiomed inspires and retains exceptional talent through collaboration, passion and continuous development.

We are searching for the best talent for our Senior Supplier Engineer (m/f/d) rolein Aachen.

Key Responsibilities:

• Act as a primary technical point of contact with suppliers who provide precision machined components and systems.

• Promote the use of Design for Manufacturing (DfM/DfX) methodologies on new product development projects with an understanding that builds long term success.

• Influence development teams and projects by representing capabilities of the supplier and being a leading force for positive improvements to design, supply and continuity.

• Shepherd Supplier Engineering innovation projects to completion by collaborating with internal and external partners.

• Partner with supplier’s engineering teams to analyze manufacturing processes and use data to develop and successfully conduct yield improvements.

• Develop inspection methods and validate through GR&R in collaboration with suppliers’ engineering teams.

• Be a technical partner with internal quality teams to assess defects and lead non-conformance investigations.

• Participate in second source selection and qualification processes at alternative suppliers.

Qualifications

Required:

• Bachelor’s degree or equivalent experience in mechanical engineering, manufacturing engineering, with plastics background or related field required.

• Proven experience in relevant engineering or quality role(s), typically for 5 or more years.

• In-depth knowledge of precision molding and plastic technologies.

• Experience working at an OEM who develops, manufactures, and/or assembles components with micron-level tolerances and high-performance materials, including stainless steels, titanium, ceramics, kanthal, and/or nitinol.

• Relevant skills collaborating with R&D and/or Other Development Resources for new product developments and innovation in MedTech, Lifesciences, Robotics, or similar High-Tech fields.

• Familiarity with ordering, receiving, and using custom direct materials, including inspection plans, MRB investigations, non-conformance handling, and ERP systems.

• Experience developing process validation plans, including IQ/OQ/PQ protocols and reports.

• Knowledge of Gauge R&R studies and performing ranging studies/DOE to optimize processes.

• Knowledge of statistical process control, including run charts, IM-R charts, setting control limits, and maintaining process control.

• Sufficient metrology skills, including experience with calipers, gauge pins, and vision systems/optical comparators to aid in information discovery.

• Good German and excellent English language skills

Preferred:

• Knowledge of FDA 21CFR820/821 and ISO 13485 requirements.

• Previous use of SAP, MS Office, Minitab

• Willingness to travel to suppliers sites

Other:

• Travel percentage: typically 20%, both national and international.

• Valid driver’s license may be required for specific roles.

The anticipated base pay range for this position is 75.000 to 118.450 EUR.

Required Skills:

Preferred Skills: