Process Engineers - 4 years +

Medtronic • Humacao, PR

4d

About The Position

Join a high-impact manufacturing engineering team responsible for production performance, product quality, and operational excellence. The Process Engineer partners with Operations, Quality, R&D, and Supply Chain to develop, optimize, and scale manufacturing processes supporting medical technologies. The role leads process improvements, technology transfers, equipment implementations, and data-driven initiatives to enhance productivity, compliance, and product reliability.

Requirements

• Senior level: Bachelor's degree in Engineering and 4 or more years of manufacturing engineering experience, or Master's degree in Engineering and 2 or more years of manufacturing engineering experience, or a PhD in Engineering.
• Principal level: Bachelor's degree in Engineering and 7 or more years of manufacturing engineering experience, or Master's degree in Engineering and 5 or more years of manufacturing engineering experience, or PhD in Engineering and 3 or more 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.
• For Baccalaureate 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

• 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.

Responsibilities

• Develop, optimize, and sustain manufacturing processes to improve quality, efficiency, throughput, and yield.
• Drive continuous improvement 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.
• Lead equipment qualification and validation activities, including IQ, OQ, and PQ.
• Partner with R&D and Product Development to ensure designs are manufacturable, scalable, and aligned with production capabilities.
• Conduct process characterization, DOE, SPC, MSA, and capability studies to support robust manufacturing processes.
• Support technology transfer, scale-up, and new product introductions, ensuring successful transition into manufacturing operations.
• Ensure compliance with FDA QSR, ISO 13485, GMP, and internal quality requirements.
• Lead risk assessments using FMEA, Fault Tree Analysis, and other risk management tools.
• Support nonconformance investigations, CAPA, engineering changes, and continuous process improvement initiatives.

Benefits

• Competitive salary and flexible benefits package.
• A wide range of benefits and resources designed to support employees at every career and life stage.
• Eligible for the short-term Medtronic Incentive Plan (MIP).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior