Process Development Engineer II - Neurovascular - Irvine, CA (Onsite)

Medtronic • Irvine, CA

238d • $80,800 - $121,200

About The Position

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. 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.

Requirements

• Bachelor's degree required with a minimum of 2 years of relevant experience OR advance degree with a minimum of 0 years of relevant experience.

Nice To Haves

• Degree in Engineering, preferably Mechanical, Electrical, or Biomedical with experience in product and/or manufacturing process development within the medical device industry.
• Proficiency in SolidWorks and a strong foundation in engineering statistics.
• In-depth knowledge of materials commonly used in medical device manufacturing, including polymers (nylons, polyethylene, polypropylene, PEEK, PTFE, FEP) and metals (nitinol, platinum, stainless steel).
• Hands-on experience with key medical manufacturing processes such as reflow/shrink processes, laser bonding and welding, thermal and adhesive bonding, braiding, coil winding, hydrophilic coating, plasma treatment, cleaning processes, and crimping.
• Experience developing and qualifying fixtures, tooling, and equipment, including conducting IQ, OQ, and PQ activities.
• Experience collaborating with OEM suppliers for component development and the selection of equipment and processes.
• Active participation on cross-functional teams responsible for new product development and successful transfer into full-scale manufacturing.
• Working knowledge of design and process FMECA (Failure Modes, Effects, and Criticality Analysis), process validation, and process control strategies.
• Familiarity with Design for Manufacturability (DFM) principles and lean manufacturing methodologies.

Responsibilities

• Develop new manufacturing processes, procedures, inspection methods, and production layout for assemblies for New Product Introductions (NPIs) through frequent interaction with R&D, Quality Engineering, and Operations using project management, design for manufacturability, and lean methodologies.
• Design, develop, and implement fixtures, tooling, and production equipment to support new and existing processes.
• Create detailed process specifications that ensure products consistently meet user needs and regulatory requirements.
• Perform equipment and process characterizations and qualifications (IQ/OQ/PQ).
• Manage development builds for new products in both pilot and production environments, including operator training, production planning coordination, material procurement, fixture and equipment setup, supervision of build activities, and resolution of assembly issues.
• Ensure full compliance with FDA regulations and applicable international standards throughout all phases of process development.
• Perform additional responsibilities as needed to support department and company objectives.

Benefits

• Competitive Salary and flexible Benefits Package
• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees