Process Engineer - Medical Device Validation & Lean

MRINetwork; Providence (RI); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

401(k) match program

Dental, health, and vision insurance

Paid time off

Job summary

MRINetwork is seeking a Process Engineer located in Providence, RI, specializing in custom solutions for the medical device and pharmaceutical sectors. The role involves optimizing product quality and ensuring regulatory compliance through collaboration with various teams.

Qualified candidates will have a Bachelor’s degree in engineering and 3-5+ years of relevant experience. Benefits include a 401(k) match, diverse insurance options, and paid time off.

Qualifications

• 3–5+ years in process engineering, manufacturing engineering, or operations engineering.
• Hands-on experience with process validation (IQ/OQ/PQ).
• Strong knowledge of FDA regulations and ISO standards.

Responsibilities

• Develop and execute validation protocols for processes.
• Define critical process parameters through development studies.
• Lead statistical analysis of validation data.

Skills

ISO 13485 expertise

Six Sigma methodology

Minitab or equivalent software

Lean Manufacturing principles

Root-cause analysis

Education

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

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

Tools

Minitab

Statistical analysis tools

Job description

MRINetwork is seeking a Process Engineer located in Providence, RI, specializing in custom solutions for the medical device and pharmaceutical sectors. The role involves optimizing product quality and ensuring regulatory compliance through collaboration with various teams.

Qualified candidates will have a Bachelor’s degree in engineering and 3-5+ years of relevant experience. Benefits include a 401(k) match, diverse insurance options, and paid time off.