Senior Process Engineer - Medical Devices, Lean & Innovation

Health Staffing Group; Minneapolis (MN); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Competitive salary

Benefits package

Retirement plan

Paid time off

Career growth

Job summary

Health Staffing Group seeks a Senior Process Engineer to lead the development, validation, optimization, and continuous improvement of manufacturing processes within a regulated medical device environment.

This role partners with Engineering, Operations, Quality, R&D, and Supply Chain to improve process capability, yield, efficiency, product quality, and cost while ensuring FDA and ISO 13485 compliance. The ideal candidate combines hands-on experience with strong problem-solving skills.

Qualifications

• Bachelor's degree in Engineering, Manufacturing, Biomedical Engineering, or related technical field.
• 5+ years of process or manufacturing engineering experience in medical devices or regulated manufacturing.
• Experience with process validation, manufacturing process development, and continuous improvement.
• Knowledge of FDA Quality System requirements and ISO 13485.
• Experience with root-cause analysis, CAPA, SPC, DOE, and process capability.
• Experience supporting NPI, design transfer, or manufacturing transfer.
• Strong analytical, communication, project management, and problem-solving skills.
• Proficiency with Microsoft Office.

Responsibilities

• Lead process development, optimization, validation, and continuous improvement initiatives.
• Develop and execute process validation activities, including IQ, OQ, and PQ.
• Analyze manufacturing data to improve yield, cycle time, throughput, capability, and cost.
• Lead root-cause investigations, CAPA, nonconformance resolution, and corrective actions.
• Support NPI, design transfer, process transfer, and production scale-up.
• Develop and maintain process specifications, work instructions, validation documentation, and engineering reports.
• Support equipment qualification, tooling, automation, and manufacturing technology improvements.
• Apply Lean, Six Sigma, SPC, DOE, PFMEA, and other process improvement methodologies.
• Partner with Quality and Regulatory teams to maintain compliance with FDA and ISO requirements.
• Lead cross-functional engineering projects and provide technical guidance to manufacturing teams.

Skills

Process optimization

Root cause analysis

CAPA

Project management

Analytical skills

Problem-solving

Communication

Microsoft Office

Education

Bachelor's degree in Engineering

Tools

Minitab

JMP

DOE

PFMEA

Job description

Health Staffing Group seeks a Senior Process Engineer to lead the development, validation, optimization, and continuous improvement of manufacturing processes within a regulated medical device environment.

This role partners with Engineering, Operations, Quality, R&D, and Supply Chain to improve process capability, yield, efficiency, product quality, and cost while ensuring FDA and ISO 13485 compliance. The ideal candidate combines hands-on experience with strong problem-solving skills.