Senior Process Engineer — Medical Device Process Excellence

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

Benefits offered by this job

Competitive salary

Medical, dental, vision

Retirement plan

Paid time off

Career development

Quality-focused culture

Job summary

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

The role requires strong technical problem-solving, hands-on manufacturing experience, and knowledge of medical device quality requirements.

Qualifications

• Bachelor's degree in Engineering, Manufacturing, Biomedical Engineering or related field.
• 5+ years in process/manufacturing engineering, preferably in medical devices or regulated manufacturing.
• Experience with process validation, development, and continuous improvement.
• Knowledge of FDA Quality System requirements and ISO 13485.

Responsibilities

• Lead development, optimization, validation and continuous improvement of manufacturing processes.
• Develop and execute IQ, OQ, and PQ for process validation.
• Analyze manufacturing data to improve yield, cycle time, throughput 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 specs, work instructions and validation docs.
• Support equipment qualification, tooling, automation and tech improvements.
• Apply Lean, Six Sigma, SPC, DOE, PFMEA and other methods.
• Partner with Quality and Regulatory to maintain FDA and ISO compliance.
• Lead cross-functional engineering projects and guide manufacturing teams.

Skills

Process development

Statistical analysis

Six Sigma

DOE

CAPA

Root cause analysis

Project management

Lean manufacturing

Microsoft Office

Education

Bachelor's degree in Engineering

Tools

Minitab

JMP

ERP

MES

Job description

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

The role requires strong technical problem-solving, hands-on manufacturing experience, and knowledge of medical device quality requirements.