Senior Process Engineer

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

The Senior Process Engineer will 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. The ideal candidate brings strong technical problem-solving skills, hands-on manufacturing experience, and knowledge of medical device quality requirements.

Key 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.

Qualifications

Required

• Bachelor's degree in Engineering, Manufacturing, Biomedical Engineering, or a related technical field.
• 5+ years of process or manufacturing engineering experience, preferably 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.

Preferred

• Experience with medical device manufacturing, automation, or advanced manufacturing technologies.
• Experience with Minitab, JMP, or similar statistical software.
• Knowledge of PFMEA, control plans, DFM/DFA, and risk management.
• Experience with ERP, MES, or manufacturing systems.

What We Offer

• Competitive salary and performance incentives.
• Medical, dental, and vision benefits.
• Employer-sponsored retirement plan.
• Paid time off and company holidays.
• Professional development and career advancement opportunities.
• Collaborative environment focused on quality and continuous improvement.