Principal Process Engineer, Advanced Manufacturing Technical Lead

MIV Medtronic Interventional Vascular Inc; Danvers (MA); On-site; USD 129,000 - 193,000; Full time

Job summary

Medtronic is seeking a Principal Process Engineer in AME to lead hands-on process development, equipment integration, and validation for scalable medical technologies. You will connect product requirements with practical manufacturing solutions and guide cross-functional teams from development through production.

The role emphasizes technical depth, mentoring, and a collaborative leadership style. It requires working onsite five days a week and partnering with R&D, Quality, Operations, and

Qualifications

• Bachelor’s degree with 7+ years of relevant experience, or an advanced degree with 5+ years.
• Experience leading process development, validation, and tech transfer in regulated environments.
• Strong knowledge of DOE, SPC, and risk management methods.

Responsibilities

• Provide hands-on technical leadership across process development, equipment selection and integration, process characterization, validation, technology transfer, and manufacturing optimization.
• Lead complex engineering initiatives from concept through implementation, balancing product requirements, quality, manufacturability, scalability, cost, and project timelines.
• Partner with R&D, Quality, Operations, Supply Chain, Regulatory Affairs, and external partners to resolve technical challenges and support successful new product introductions and ongoing manufacturing.
• Evaluate manufacturing approaches and emerging technologies, including automation and digital manufacturing capabilities, and recommend solutions.
• Lead process characterization and establish effective process controls using DOE, SPC, capability analysis, and data-driven decision-making.
• Guide process risk assessments, validation strategies, and execution of IQ/OQ/PQ activities in accordance with quality and regulatory requirements.
• Lead investigations into complex manufacturing issues, identifying root causes and implementing sustainable corrective actions.
• Mentor engineers across levels, strengthening technical skills and project ownership.

Skills

Technical leadership

DOE

SPC

IQ/OQ/PQ

FMEA

Cross-functional collaboration

Mentoring

Education

Bachelor's degree + 7+ years

Advanced degree + 5+ years

Job description

We anticipate the application window for this opening will close on 23 Sep 2026. 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 Principal Process Engineer in AME organization.

As a Principal Process Engineer on Medtronic’s Advanced Manufacturing Engineering (AME) team, you will combine broad, hands‑on engineering experience with strong technical leadership to support the development, commercialization, and scale‑up of life‑saving medical technologies. In this role, you will apply a well‑rounded background across manufacturing processes, equipment, materials, process development, validation, and continuous improvement to solve complex challenges and guide engineering decisions. You will connect product requirements with practical manufacturing solutions, supporting programs from early development through production. You will also help strengthen the team’s technical capabilities by mentoring engineers, coaching structured problem‑solving, sharing knowledge, and guiding cross‑functional teams. Success requires technical depth, the ability to work across engineering disciplines, and a collaborative leadership approach that builds confidence, accountability, and sound engineering judgment in others. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In‑person exchanges in a manufacturing environment are invaluable to our work. This role requires working onsite a minimum of five days per week to support professional growth and cross‑functional collaboration as we work together to engineer the extraordinary.

Responsibilities

• Provide hands‑on technical leadership across process development, equipment selection and integration, process characterization, validation, technology transfer, and manufacturing optimization.
• Apply broad engineering knowledge to evaluate how materials, equipment, tooling, process parameters, and product design interact to influence manufacturing performance.
• Lead complex engineering initiatives from concept through implementation, balancing product requirements, quality, manufacturability, scalability, cost, and project timelines.
• Partner with R&D, Quality, Operations, Supply Chain, Regulatory Affairs, and external partners to resolve technical challenges and support successful new product introductions and ongoing manufacturing.
• Evaluate manufacturing approaches and emerging technologies, including automation and digital manufacturing capabilities, and recommend solutions appropriate to the application.
• Lead process characterization and establish effective process controls using Design of Experiments (DOE), Statistical Process Control (SPC), capability analysis, and data‑driven decision‑making.
• Guide process risk assessments, validation strategies, and execution of IQ/OQ/PQ activities in accordance with applicable quality system and regulatory requirements.
• Lead investigations into complex manufacturing issues, working directly with teams to identify root causes, evaluate solutions, and implement sustainable corrective and preventive actions.
• Mentor and coach engineers across experience levels, helping them strengthen technical skills, troubleshooting approaches, engineering judgment, and project ownership.
• Review engineering studies, technical documentation, and proposed solutions; provide constructive feedback and help teams understand the reasoning behind technical decisions.
• Foster a collaborative environment where engineers ask questions, share knowledge, challenge assumptions respectfully, and learn from project outcomes.
• Lead through influence by aligning cross‑functional teams on technical priorities, communicating tradeoffs clearly, and guiding decisions when requirements or solutions are uncertain.
• Contribute to manufacturing technology roadmaps, capital planning, equipment selection, and expansion strategies, while sharing lessons learned and best practices across teams and sites.

Must Have

• Minimum Requirements Bachelor’s degree with a minimum of 7 years of relevant experience.
• OR Advanced degree with a minimum of 5 years of relevant experience.

Nice to Have

• Preferred Qualifications Broad, hands‑on engineering experience spanning multiple areas of manufacturing, such as process development, equipment and tooling, materials processing, validation, production support, and continuous improvement.
• Experience in medical device, pharmaceutical, biotechnology, or other highly regulated manufacturing environments.
• Demonstrated ability to work across multiple manufacturing technologies and apply engineering fundamentals to unfamiliar processes or technical challenges.
• Experience with plastics processing, including injection molding or extrusion, complex assembly processes, automation, robotics, or equipment integration.
• Experience supporting products through multiple lifecycle stages, from development and commercialization to manufacturing scale‑up and ongoing process optimization.
• Demonstrated technical leadership through mentoring, coaching, knowledge sharing, and guiding engineers through complex projects and problem‑solving activities.
• Ability to provide actionable technical feedback, adapt coaching to different experience levels, and support the development of independent engineering judgment.
• Experience leading cross‑functional technical initiatives and building alignment across teams, sites, and organizational levels.
• Strong working knowledge of process validation, risk management methods such as FMEA, statistical analysis, DOE, SPC, and process capability.
• Demonstrated success resolving complex manufacturing problems through hands‑on investigation, structured analysis, and sustainable solutions.
• Design, Reliability and Manufacturability (DRM) Green belt or Black belt certification or equivalent experience.
• Strong communication skills, including the ability to explain technical concepts, recommendations, and tradeoffs to engineering teams, operational partners, and senior leadership.
• 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. Salary ranges for U.S (excl. PR) locations (USD):$128,800.00 - $193,200.00 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.

Equal Employment Opportunity

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.

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.

Additional Information & Policies

For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E‑Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E‑Verify program, please click here.