Medtronic

Sr. Process Engineer (Operations/Manufacturing)

In short

Senior Process Engineer role at Medtronic's Mounds View, MN site, supporting manufacturing readiness and production ramp of a new medical device product within the CAS portfolio, with about 25% travel. The role partners with R&D, Quality, Sourcing, Regulatory, Operations and a contract manufacturer to drive process validation (IQ/OQ/PQ), statistical analysis (Minitab, Cpk, ANOVA, MSA/GR&R) and risk reviews (DFMEA/PFMEA). Requires a Bachelor's degree with 4+ years of relevant experience (or Master's with 2+ years, or PhD) in regulated manufacturing environments, plus proven cross-functional and supplier collaboration experience. U.S. work authorization sponsorship is not offered for this level; candidates must have unrestricted U.S. work authorization.

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.
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.
U.S. Work Authorization & Sponsorship
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.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package.
Salary ranges for U.S (excl. PR) locations (USD): $103,200.00 - $154,800.00
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.

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