Process Development Engineer II - Santa Ana, CA

Posted:
7/1/2025, 11:35:16 PM

Location(s):
California, United States ⋅ Santa Ana, California, United States

Experience Level(s):
Junior ⋅ Mid Level

Field(s):
Product

We anticipate the application window for this opening will close on - 11 Jul 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

Careers that Change Lives
A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.

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.

A Day in the Life

Be a part of a dynamic team that designs and develops manufacturing processes for new heart valve therapies from concept through design transfer and product launch. This process development team is committed and driven in our mission to revolutionize the way we manufacture heart valves while producing a high-quality product for our patients and customers.

The ideal candidate will have a passion for advanced manufacturing and the development of manufacturing processes for bioprosthetic heart valve implants during product development phases. The candidate will be well versed at process development, setting up manufacturing operations, and interfacing cross-functionally with other key engineering expertise to develop a product.

In this role, you will act under the general supervision of an Engineering Manager and within product development teams on multiple assignments of varying scope and complexity. Most of your work will involve close collaboration and dynamic interactions with R&D and Design Assurance regarding products in the development pipeline and with operation team members for new or iterative product implementation.

Careers that Change Lives 

A career at Medtronic is like no other. We’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide. 

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day.  

 

Our Purpose 

At our Structural Heart & Aortic Advanced Manufacturing (AME) Engineering team in Santa Ana, Medtronic, plc, we focus designing and developing cutting-edge technologies for the manufacture of bioprosthetic heart valve in the Cardiovascular Portfolio. Our Engineers are directly involved in the development of innovative products and processes for use in medical procedures. 

Come for a job, stay for a career! 

 
A Day in the Life 

As an engineer you will actively participate in all areas of new product development for bovine and porcine heart valves, including the following: Technology Development & Advancement, Process Development, Mechanization & Semi Automation, Vendor Management & Project Management. 

Process Technologies: 

You will support teams driving technology innovation with emphasis on improving quality, technical rigor and developing state-of-the-art mechanized and semi-automated systems. 

  • Support feasibility or proof of principle studies that explore new process technologies and evaluate its potential for application to bioprosthetic heart valve manufacturing. 

  • Analyze results and make recommendations.  

 

 

Process Development 

You will use Design, Reliability & Manufacturability methodology (DRM), and 3-D drawing to develop best in class processes and manufacturing lines for the manufacture of our heart valve product ranges. 

  • You will support process development, characterization, and validation (IQ, OQ, PQ) activities to support new product introduction.  

  • You will collaborate with cross-functional teams, primarily R&D, Operations and Quality, to define, execute, and deliver on New Product Development requirements. 

  • You will compile, document, and present all learnings to project and functional teams e.g., Technical Reviews, Design Reviews, Project Dashboards, process Development reports. 

  • You will participate in functional initiatives that support the continuous improvement of the Process Development organization. 

 

Process Transfer 

Support activities that are required for transfer of pilot line/ developed processes during product development phase to commercial operations. Such activities include, but are not limited to, the following: 

  • Transfer Plan: Support the development and implementation of transfer plan activities. Ensure pilot line transfer, process transfer, and/or process technology are implemented efficiently and effectively into commercial production or receiving site. 

  • Qualification and Validation: Generate and execute plans for equipment qualification and process validation. Develop plans to evaluate process capability. Support test method development and validation where needed.  

  • Production Support and Trouble Shooting:   Provide engineering support to manufacturing operation on routine basisInvestigate and address product related issues arising on the pilot line and production line following process transfer.  

  

Key Skills & Experience 

  • Bachelor of Science Degree in a related engineering discipline (i.e., mechanical, biomedical, industrial, materials science) 

  • 2+ years in manufacturing environment and/or product/process development 

  • Dynamic team player and can work effectively and proactively on cross functional teams. 

  • Knowledge of medical device processes with a good understanding of product and process design. 

  • Good communicator and fluent in English, with a high level of enthusiasm and motivation. 

  • Good organizational, presentation and project management skills are desirable. 

 

Nice to Have 

  • Demonstrated problem-solving and critical thinking experience 

  • Solid understanding of statistical techniques and analysis  

  • Experience with designing tooling/fixture design and qualification 

  • Experience with Solidworks 

  • Previous experience working in and/or designing for a clean room environment 

  • Experience with cardiovascular and/or tissue-based products 

 

About Medtronic 

 

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend lifeWe challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. 

 

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future. 

 

Physical Job Requirements 

 

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. (ADA-United States of America) 

 

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 base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

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.