Process Engineer - 4 years +

Medtronic plc; United States; On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Short-term incentive (MIP)

Job summary

Medtronic plc is seeking an experienced Manufacturing Engineer to drive development and optimization of production processes across R&D, Operations, and Quality. You will lead equipment qualifications, data-driven improvements, and scalable manufacturing initiatives for medical technologies.

The role emphasizes Lean Six Sigma, DOE, SPC, MSA, and regulatory compliance to ensure high-quality, reliable production.

Qualifications

• Bachelor's degree in Engineering and 4+ years of manufacturing engineering experience (Senior)
• Master's degree in Engineering and 2+ years of manufacturing engineering experience (Senior)
• PhD in Engineering with related experience (Senior/Principal)
• Experience applying Lean Manufacturing and Six Sigma in regulated manufacturing environments
• Experience with advanced statistical tools (DOE, SPC, MSA, capability analysis)
• Experience leading equipment qualifications and process validations (IQ/OQ/PQ)

Responsibilities

• Lead development, optimization, and sustainment of manufacturing processes to improve quality, throughput, and yield
• Drive continuous improvement using Lean, Six Sigma, and statistics
• Identify and implement equipment, tooling, automation, and process enhancements
• Lead equipment qualification and validation activities (IQ/OQ/PQ)
• Collaborate with R&D and Product Development to ensure manufacturability and scalability
• Conduct DOE, SPC, MSA, and capability studies for robust processes
• Support technology transfer, scale-up, and new product introductions
• Ensure compliance with FDA QSR, ISO 13485, GMP and internal quality requirements
• Lead risk assessments (FMEA, Fault Tree) and CAPA activities
• Support nonconformance investigations and engineering changes

Skills

Lean Manufacturing

Six Sigma

DOE

SPC

MSA

FMEA

CAPA

Education

Bachelor's degree in Engineering

Master's degree in Engineering

PhD in Engineering

Tools

Minitab

JMP

Power BI

Python

Job 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

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 high-impact manufacturing engineering team responsible for advancing production performance, product quality, and operational excellence. This role partners closely with Operations, Quality, R&D, and Supply Chain to develop, optimize, and scale manufacturing processes that support innovative medical technologies. The engineer will lead strategic process improvements, technology transfers, equipment implementations, and data-driven initiatives that enhance productivity, compliance, and product reliability.

Primary Responsibilities

• Lead the development, optimization, and sustainment of manufacturing processes to improve quality, efficiency, throughput, and yield.
• Drive continuous improvement initiatives using Lean Manufacturing, Six Sigma, and statistical methodologies to reduce waste and improve process capability.
• Identify, evaluate, and implement equipment, tooling, automation, and process enhancements to support operational objectives.
• Lead equipment qualification and validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Partner with R&D and Product Development teams to ensure designs are manufacturable, scalable, and aligned with production capabilities.
• Conduct process characterization, Design of Experiments (DOE), Statistical Process Control (SPC), Measurement System Analysis (MSA), and capability studies to support robust manufacturing processes.
• Support technology transfer, scale-up activities, and new product introductions, ensuring successful transition into manufacturing operations.
• Ensure compliance with FDA Quality System Regulations (QSR), ISO 13485, Good Manufacturing Practices (GMP), and internal quality requirements.
• Lead risk assessments using Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis, and other risk management tools.
• Support nonconformance investigations, Corrective and Preventive Actions (CAPA), engineering changes, and continuous process improvement initiatives.

Required Qualifications

Senior Level

• Bachelor's degree in Engineering and 4+ years of manufacturing engineering experience OR Master's degree in Engineering and 2+ years of manufacturing engineering experience OR PhD in Engineering.

Principal Level

• Bachelor's degree in Engineering and 7+ years of manufacturing engineering experience OR Master's degree in Engineering and 5+ years of manufacturing engineering experience OR PhD in Engineering and 3+ years of manufacturing engineering experience.
• Experience applying Lean Manufacturing and Six Sigma methodologies in a regulated manufacturing environment.
• Experience with advanced statistical tools, including DOE, SPC, MSA, and process capability analysis.
• Experience leading equipment qualifications and process validations (IQ/OQ/PQ).
• Knowledge of FDA QSR, ISO 13485, GMP, and quality system requirements.
• Experience supporting nonconformance investigations, CAPA activities, and engineering change implementation.

Preferred Qualifications

• Lean Six Sigma Green Belt or Black Belt certification.
• Experience with automation, digital manufacturing, Industry 4.0, or smart factory technologies.
• Experience using Minitab, JMP, Power BI, Python, or other advanced data analytics tools.
• Experience with Design for Manufacturability (DFM) and Design for Assembly (DFA) in partnership with R&D teams.
• Experience leading technology transfer, process scale-up, and new product introduction projects.
• Experience with supplier process development, qualification, and performance improvement initiatives.
• Project management experience, including cross-functional leadership of technical initiatives.
• Experience mentoring junior engineers and providing technical leadership across teams.
• Strong technical writing skills for protocols, validation reports, and regulatory documentation.
• Demonstrated success driving cost reduction, value engineering, and operational excellence initiatives.

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.

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).

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.