Process Engineer - Medical Devices (Validation, DOE & Lean)

Management Recruiters of Tallahassee; Providence (RI); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

401(k) match program

Dental insurance

Health insurance

Vision insurance

Paid time off

Job summary

Management Recruiters of Tallahassee is hiring a Process Engineer in Providence, RI. This role involves working closely with Operations and Quality teams to optimize product quality and compliance in manufacturing processes.

The ideal candidate will have 3-5+ years in process engineering, expertise in ISO standards, and proficiency in Minitab. Key responsibilities include developing validation protocols and training production teams. Benefits include 401(k) match and health insurance.

Qualifications

• 3-5+ years in process engineering within a regulated industry; medical device experience preferred.
• Strong knowledge of ISO 13485 and FDA 21 CFR Part 820.
• Demonstrated expertise in DOE and Six Sigma methodology.

Responsibilities

• Develop and execute validation protocols for thermoforming and sealing processes.
• Lead statistical analysis of validation data for critical parameters.
• Train production teams on validated processes and critical quality attributes.

Skills

Process validation (IQ/OQ/PQ)

Statistical analysis

Lean Manufacturing

Six Sigma methodology

Minitab or equivalent software

Root cause investigations

Leadership skills

Education

Bachelor's degree in Mechanical, Manufacturing, Industrial, Chemical Engineering, or a related field

Advanced degrees or certifications (Six Sigma, CQE, CQA)

Tools

Minitab

Heat sealing equipment

Statistical Process Control (SPC)

Job description

Management Recruiters of Tallahassee is hiring a Process Engineer in Providence, RI. This role involves working closely with Operations and Quality teams to optimize product quality and compliance in manufacturing processes.

The ideal candidate will have 3-5+ years in process engineering, expertise in ISO standards, and proficiency in Minitab. Key responsibilities include developing validation protocols and training production teams. Benefits include 401(k) match and health insurance.