Process Engineer II - NV - Irvine, CA (Onsite)

Medtronic

4d • Onsite

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. A Day in the Life Our Neurovascular Operating Unit develops and delivers advanced, minimally invasive endovascular technologies for the treatment of acute ischemic and hemorrhagic stroke, brain aneurysms, and other complex cerebrovascular conditions. Through catheters, stent retrievers, flow diversion, and embolization systems, these solutions enable rapid, image-guided interventions that restore blood flow, secure vessels, and support consistent performance in high-acuity neurovascular procedures. Check us out on LinkedIn: Medtronic Neurovascular As a Process Engineer II, you will work closely with R&D, Operations and Quality in the development of processes necessary to Product Delivery System, Stents, Coils, Catheters, other medical devices for a lean manufacturing environment. The ideal candidate will have prior experience working in the medical device industry developing new manufacturing processes, implementing and qualifying production equipment and methods, managing development builds, generating testing protocols and reports, and working with minimal direction for New Product Introductions. Onsite At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

Requirements

• Bachelor’s degree in Mechanical, Electrical or Biomedical Engineering with minimum of 2 years of experience developing products and/or manufacturing processes in medical device industry, OR Master’s degree in Mechanical, Electrical or Biomedical Engineering with minimum of 0 years of experience developing products and/or manufacturing processes in medical device industry

Nice To Haves

• Knowledge of materials used in medical device manufacturing, including polymers (e.g., nylon, polyethylene, polypropylene, PEEK, PTFE, FEP) and metals (e.g., nitinol, platinum, stainless steel).
• Hands-on experience with medical manufacturing processes such as reflow/shrinking, laser bonding and welding, thermal and adhesive bonding, braiding, coil winding, hydrophilic coating, plasma treatment, cleaning, crimping, heat setting, electropolishing, and swaging.
• Experience in development, design support, and qualification of fixtures, tooling, and equipment (IQ/OQ/PQ).
• Experience collaborating with external OEM suppliers for component development and selection of equipment and processes.
• Proven involvement in cross-functional project teams supporting new product development and successful transfer to manufacturing.
• Knowledge of design and process FMECA, process validation, and process control methodologies.
• Familiarity with design for manufacturability (DFM) and lean manufacturing principles.
• Working knowledge of SolidWorks and engineering statistics.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Responsibilities

• Develop and optimize manufacturing processes for new product introductions in collaboration with R&D, Quality Engineering, and Operations.
• Design and implement manufacturing procedures, inspection methods, and production layouts using project management, design for manufacturability, and lean principles.
• Create and support development of fixtures, tooling, and equipment.
• Establish process specifications to ensure alignment with user and product requirements.
• Perform equipment and process characterization and qualifications (IQ/OQ/PQ).
• Lead pilot and production builds, including operator training, production planning coordination, and preparation of manufacturing documentation.
• Troubleshoot assembly and process issues during development and production phases.
• Ensure compliance with FDA and applicable international regulatory standards.
• Support continuous improvement initiatives and perform additional duties as assigned.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• 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, and 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), and 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: Mid Level