Process Engineer II at Medtronic in Fridley, Minnesota

Job Description:

We anticipate the application window for this opening will close on - 1 Jan 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
We anticipate the application window for this opening will close on - 1 January 2025.

The Rice Creek Pharma Operations Advanced Manufacturing Engineering Process Engineer II is responsible for evaluating, improving, and controlling the overall performance of manufacturing areas that provide implantable components and finished devices, including combination products. This role involves leading and collaborating closely with Operations, Quality, Reliability Engineering, and Regulatory Affairs. The Process Development Engineer plays a crucial role in introducing new processes into manufacturing and providing technical solutions to product performance issues.

Rice Creek Pharma Ops seeks candidates who strive to meet our customers' expectations by ensuring the highest possible reliability and quality in our products, processes, and systems. We value accountability, encourage open communication, and taking proactive action.
Responsibilities may include the following and other duties may be assigned.

• Develop, characterize, and validate medical device manufacturing processes.


• Set objectives for production release of finished goods and components, including BOMs/routings and other ERP-required information.


• Develop solutions to complex problems and make moderate to significant improvements to processes, systems, or products independently to enhance performance.


• Work independently on larger, moderately complex projects and assignments.


• Utilize appropriate quality tools, such as DOE, SPC, hypothesis testing, and capability studies, to measure, monitor, improve, and control the manufacturing line and select processes.


• Lead failure analysis and issue resolution activities to ensure preventative actions are accomplished.


• Identify process improvement opportunities and provide technical solutions through analysis and hands-on interaction with designated processes.


• Contribute to the completion of process development and validation projects on time and within budget.


• Create written documents, test plans, and reports that demonstrate the technical rationale for associated decisions (e.g., qualifications, risk assessments, and work instructions).


• Collaborate with product development engineering to integrate lessons learned as new products are developed.


• Provide training and certification for trainers as required.


• Lead efforts to investigate and develop new technology related to combination products.

Must Have: Minimum Requirements

• Bachelor of Science in Engineering and a minimum of 2 years of relevant experience, or an advanced degree with a minimum of 0 years of relevant experience in the medical device, pharmaceutical, or highly regulated industry.

Nice to Have

• Understanding and broad application of technical principles, theories, and concepts of manufacturing processes.


• Technical knowledge of manufacturing processes.


• Experience handling multiple tasks concurrently.


• Work experience with FDA Quality System Regulations, ISO 13485, ISO 9001 standards, or equivalent.


• Experience executing process validation activities (installation qualifications, process characterization, operational and performance qualifications).


• Excellent data analysis skills, proficient in using statistical tools for problem-solving.


• Experience with design of experiments (DOE), process failure mode and effects analysis (PFMEA), and control/monitoring plans.


• Excellent technical writing skills.

Physical Requirements:

• Occasional lifting/carrying of up to 20 lbs.


• Ability to bend/stoop/kneel for a minimum of 1 hr/day.


• Ability to stand/sit/walk for 8 hrs/day.


• Perform fine close work with a microscope for 2 hrs/day.


• Dexterity required.


• Exposure to chemicals/solvents.


• Clean/dry room - gowning/glove requirements.


• Eye protection 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.

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):$79,200.00 - $118,800.00

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 90,000+ 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.