Senior Process Engineer

Health Staffing Group; Minneapolis (MN); On-site; USD 110,000 - 145,000; Full time

Benefits offered by this job

Competitive salary

Medical, dental, and vision benefits

Employer-sponsored retirement plan

Paid time off and holidays

Professional development and career Op

Job summary

Health Staffing Group seeks a Senior Process Engineer to lead development, validation, optimization, and continuous improvement of manufacturing processes in a regulated medical device environment. You will collaborate with Engineering, Operations, Quality, R&D, and Supply Chain to improve process capability, yield, efficiency, product quality, and cost.

The ideal candidate brings hands-on manufacturing experience, strong problem-solving skills, and knowledge of FDA QSR and ISO 13485, with

Qualifications

• 5+ years of process/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.

Responsibilities

• Lead process development, optimization, validation, and continuous improvement initiatives.
• Develop and execute process validation activities (IQ/OQ/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 tech improvements.
• Apply Lean, Six Sigma, SPC, DOE, PFMEA, and other process improvement methodologies.
• Partner with Quality and Regulatory teams to maintain FDA and ISO compliance.
• Lead cross-functional engineering projects and provide technical guidance to manufacturing teams.

Skills

Analytical skills

Communication skills

Project management

Problem-solving

Education

Bachelor's degree in Engineering/Manufacturing/Biomedical Engineering or related field

Tools

Microsoft Office

Minitab

JMP

Job description

Job Title: Senior Process Engineer

Reports To: Director of Engineering / Operations

Job Type: Full-Time

Department: Engineering / Operations

About the Role

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

• Lean Six Sigma certification.
• 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.

Travel: Up to 15% as needed.

Thank you,