Sr. Process Engineer (Operations/Manufacturing)
Description
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the Life
This role will sit in Mounds View, MN and have around 25% (+/-) travel.
As a Sr. Process Engineer you will be part of the OU Operations team supporting the development and production ramp of a new product development program for the CAS portfolio.
In this role, you will partner closely with R&D, Quality, Sourcing, Regulatory, Operations, and contract manufacturing teams to enable manufacturing readiness, process stability, and successful product launch. You will help drive the transition from development to production by supporting process development, qualification, validation, and technical issue resolution at the contract manufacturer.
Primary Responsibilities
- Own manufacturing readiness activities in support of NPD development and production ramp.
- Partner closely with the contract manufacturer to ensure process capability, launch readiness, and sustained production performance.
- Plan, track, and communicate progress against quality, cost, and timeline commitments.
- Collaborate with R&D, Quality, Sourcing, Regulatory, Operations, and supplier teams to drive program execution and resolve technical issues.
- Identify risks, challenges, and constraints early and lead mitigation actions with cross-functional partners.
- Facilitate supplier and cross-functional reviews to support alignment, decision-making, and program governance.
- Provide technical support to the contract manufacturer by interpreting product drawings, reviewing manufacturing drawings, and resolving production-related technical issues.
- Support process development and optimization for injection molding, stamping, pressure die casting, cleanroom manufacturing, and other regulated manufacturing environments.
- Use Minitab and statistical tools to perform process capability studies, including Cpk and related process performance analysis.
- Conduct ANOVA, regression, criticality analysis, and data-driven studies to improve process reliability and quality.
- Perform Measurement System Analysis, including GR&R studies, and identify appropriate MSA methods for process and inspection needs.
- Partner with Quality during risk management activities and actively participate in design and process reviews, including DFMEA and PFMEA.
- Other duties may be assigned
Required Qualifications
- Requires a Baccalaureate degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.
- Experience supporting process validation and qualification activities, including IQ, OQ, and PQ.
- Experience applying statistical methods such as process capability analysis, Analysis of Variance (ANOVA), regression analysis, or Measurement System Analysis (MSA).
- Experience supporting manufacturing operations within regulated environments.
- Proven experience working with cross-functional teams and external manufacturing partners.
Preferred Qualifications
- Experience and working knowledge of FDA regulations/ISO standards for medical devices
- Demonstrated ability to positively influence strategies and outcomes
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.
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Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
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If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com.
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 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
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.