Senior Process Engineer - Manufacturing Innovation

Medtronic; Humacao (PR); On-site; USD 90,000 - 140,000; Full time

Job summary

Medtronic seeks a Senior Process Engineer to lead process development, optimization, and validation in regulated manufacturing environments. You will drive continuous improvement, ensure compliance with quality and regulatory standards, and collaborate across R&D, Quality, Operations, and Supply Chain.

Responsibilities include technical and sustaining engineering support, equipment modifications for quality and yield, process transfer, and statistical analysis to improve efficiency and

Qualifications

• Lean Manufacturing & Six Sigma (Green Belt or Black Belt certification)
• Advanced statistical analysis (DOE, SPC, MSA, process capability studies)
• Automation and digital manufacturing experience
• Equipment qualification & validation leadership (IQ/OQ/PQ)
• Risk management tools (FMEA, Fault Tree Analysis)
• Regulatory knowledge (FDA QSR, ISO 13485, GMP)
• Design for Manufacturability (DFM/DFA) collaboration with R&D
• Change management & ECO execution
• Data analytics tools (Minitab, JMP, Power BI, Python for data analysis)
• Supplier process development & oversight
• Technology transfer / scale‑up experience
• Cost reduction and value engineering
• Project management (Agile, PMP fundamentals)
• Mentoring or technical coaching of junior engineers
• Strong technical writing (protocols, reports, submissions support)
• Experience in Nonconformance investigations (NCMR, CAPA investigation)

Responsibilities

• Provides technical and sustaining engineering support in a manufacturing area.
• Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products.
• Integrates equipment and material capabilities to meet process module target specifications and technology target specifications.
• Reviews product development requirements for compatibility with processing methods to determine costs and schedules.
• Interacts with product design and development personnel to ensure that processes and designs are compatible.
• May develop and conduct statistical analysis or recommend additions to document work.
• Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations.
• This can include scouting and feasibility work, material selection, process and equipment selection, tooling / fixture and equipment installation and assessment of inputs, outputs and alignment to requirements.
• Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems.
• Ensures processes and procedures are in compliance with regulations.

Skills

Lean Six Sigma

DOE/SPC/MSA

Automation

IQ/OQ/PQ

Regulatory knowledge

DFM/DFA

Change management

Data analytics

Mentoring

Agile / PMP

Root cause analysis

Technical writing

Nonconformance investigations

Education

Bachelor's degree in engineering

Master's degree in engineering

PhD in engineering

Tools

Minitab

JMP

Power BI

Python

Job description

Medtronic seeks a Senior Process Engineer to lead process development, optimization, and validation in regulated manufacturing environments. You will drive continuous improvement, ensure compliance with quality and regulatory standards, and collaborate across R&D, Quality, Operations, and Supply Chain.

Responsibilities include technical and sustaining engineering support, equipment modifications for quality and yield, process transfer, and statistical analysis to improve efficiency and