Process Engineer II - NV - Irvine, CA (Onsite)
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.
As Process Engineer II, your responsibilities will be as follow but not limited to:
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.
Must Have: Minimum 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 Have: Preferred Qualifications
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.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
U.S. Work Authorization & Sponsorship
At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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).
The following benefits and additional compensation are available to all regular employees: 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).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
