Senior Process Engineer – Advanced Manufacturing Tech 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

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