Sr. Process Engineer (Operations/Manufacturing)

Medtronic•Mounds View, MN

About The Position

The Sr. Process Engineer is part of Medtronic’s OU Operations team, supporting development and production ramp for a new product development program in the CAS portfolio. Based in Mounds View, Minnesota, the role involves approximately 25% travel. The engineer partners with R&D, Quality, Sourcing, Regulatory, Operations, and contract manufacturing teams to achieve manufacturing readiness, process stability, and successful product launch. The role supports the transition from development to production through process development, qualification, validation, and resolution of technical issues at the contract manufacturer.

Requirements

Bachelor’s degree and at least 4 years of relevant experience, or a master’s degree and at least 2 years of relevant experience, or a PhD with 0 years of relevant experience.
Experience supporting process validation and qualification activities, including IQ, OQ, and PQ.
Experience applying statistical methods such as process capability analysis, ANOVA, regression analysis, or Measurement System Analysis (MSA).
Experience supporting manufacturing operations in regulated environments.
Proven experience working with cross-functional teams and external manufacturing partners.
For bachelor’s degrees earned outside the United States, a degree satisfying the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Nice To Haves

Experience and working knowledge of FDA regulations and ISO standards for medical devices.
Demonstrated ability to positively influence strategies and outcomes.

Responsibilities

Own manufacturing readiness activities supporting new product development and production ramp.
Partner 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 execute the program 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 on risk management and participate in design and process reviews, including DFMEA and PFMEA.
Perform other duties as assigned.

Benefits

Competitive salary and flexible benefits package.
Health insurance.
Dental insurance.
Vision insurance.
Health Savings Account.
Healthcare Flexible Spending Account.
Life insurance.
Long-term disability leave.
Dependent daycare spending account.
Tuition assistance or reimbursement.
Global well-being program (Simple Steps).
Short-term incentive through the Medtronic Incentive Plan (MIP).
Incentive plans.
401(k) plan with 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.
Capital Accumulation Plan, available to Vice Presidents and above or subject to IRS earning minimums.