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

We anticipate the application window for this opening will close on - 23 May 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 exciting role as the Process Development Engineer II, you will work closely with R&D, Operations and Quality in the development of processes necessary to produce new Neurovascular Catheter products 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.

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

• 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.

Location: Irvine, CA (Onsite)

Ability to travel up to: <10%

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 2 years of relevant experience

• OR advance degree with a minimum of 0 years of relevant experience

Nice to Have (Preferred Qualifications)

• 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.

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.

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.
 

Salary ranges for U.S (excl. PR) locations (USD):$80,800.00 - $121,200.00

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.