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Senior Principal Process Engineer (AME) - Neurovascular - Irvine, CA (Onsite)

Medtronic
USA-CA, United States, United Statesfull_timeVerifiedPosted 27 May 2025
💰 $224,400/yr

About the role

We anticipate the application window for this opening will close on - 13 Jun 2025


 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

For over a decade, Medtronic has been at the forefront of transforming stroke care, leading the fight against both acute ischemic stroke (AIS) and hemorrhagic stroke. By equipping physicians with innovative technologies, we empower their expertise to improve patient outcomes and redefine neurovascular care. Our commitment extends beyond medical device development—we actively collaborate with the medical community to drive meaningful advancements in stroke treatment. Together, we are changing the way stroke is managed worldwide, making a lasting difference for the millions of patients affected every day.

Join a diverse team of innovators who bring their worldview, their unique backgrounds and their individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

Learn more about Neuro Vascular:  Click Here

#Neuroscience

Careers That Change Lives

In this dynamic role as a Senior Principal Process Engineer within AME team, you will play a critical role in advancing existing technologies and introducing innovative manufacturing processes, with a primary focus on neurovascular catheter production. Partnering closely with R&D, Operations, and Global Manufacturing teams, you will lead strategic process development initiatives from concept through implementation, ensuring robust process controls, readiness for high-volume manufacturing, and full regulatory compliance.

You will be responsible for selecting, developing, and validating manufacturing systems and processes to produce high-quality, cost-effective commercial medical devices. As the technical lead, you will lead a team of 5+ engineers, driving the development, validation, and continuous improvement of manufacturing processes to support New Product Introductions (NPIs) and ongoing production needs.

This role demands innovation, advanced project management capabilities, and the ability to navigate and solve complex, cross-functional challenges that impact manufacturing scalability, cost efficiency, and product quality.

Responsibilities may include the following and other duties may be assigned.

  • Lead early technology identification, feasibility studies, and pilot line development for New Product Introductions (NPIs).

  • Design, develop, and validate manufacturing processes, equipment, and fixtures; manage equipment qualification (IQ/OQ/PQ) and process validation efforts.

  • Collaborate closely with cross-functional teams to drive Pre-market process improvements and smooth design transfer to Operations.

  • Conduct feasibility studies for new process technologies, support first principles engineering rigor, and apply six sigma and lean methodologies.

  • Mentor teams on best practices in process development, validation, and manufacturing excellence.

  • Address strategic process improvements, CAPAs, product stabilization, and manufacturing optimization initiatives.

  • Communicate and influence stakeholders across technical and leadership levels, including external suppliers and vendors.

  • Generate required technical documentation (protocols, reports, FMEAs, manufacturing instructions) while ensuring adherence to GMP and regulatory standards.

Location: Irvine, CA and Santa Ana, CA

Ability to travel up to: 25-50% between Irvine, CA and Santa Ana, CA

Must Have (Minimum Requirements)

To be considered for this role, please ensure the minimum requirements are evident on your resume.

  • Bachelor’s degree required with a minimum of 10 years of relevant experience

  • OR advance degree with a minimum of 8 years of relevant experience

Nice to Have (Preferred Qualifications)

  • Degree in Mechanical Engineering or related Engineering field is highly preferred.

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Company

Medtronic

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