Senior Process Engineer, Medical Device Packaging

Crosslinked; Providence (NC); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

401(k) match program

Dental, health, and vision insurance

Paid time off

Job summary

Crosslinked is seeking a Senior Process Engineer for its Providence, RI location to validate and optimize thermoforming and heat-sealing processes for medical device packaging components. You will lead IQ/OQ/PQ validation activities, define CPPs/NOR, and drive continuous improvement across Operations, Quality, and Design teams.

The role requires 3–5+ years in a regulated environment, working knowledge of ISO 13485 and FDA 21 CFR Part 820, and strong DOE/Six Sigma capabilities.

Qualifications

• 3–5+ years in process/ manufacturing engineering within a regulated industry (medical device preferred).
• Experience with IQ/OQ/PQ validation in FDA/ISO contexts.
• Strong knowledge of ISO 13485 and FDA 21 CFR Part 820; audit SME capabilities.
• Demonstrated DOE and Six Sigma expertise; Black Belt preferred.
• Proficiency with Minitab for capability analysis, SPC, and DOE; CAPA experience.

Responsibilities

• Develop and execute IQ/OQ/PQ validation protocols for thermoforming and sealing processes per ISO 11607-2 and FDA guidance.
• Define CPPs, PAR, and NOR through structured development studies and DOE.
• Lead statistical analysis of validation data; target Cpk ≥ 1.33 for critical parameters.
• Own full three-stage validation lifecycle: Process Design, Qualification, and Continued Verification.
• Define and optimize process parameters (temperature, vacuum/pressure, cycle times).
• Lead equipment qualification (IQ/OQ) for supporting equipment.
• Ensure compliance with ISO 13485, ISO 11607-1/2 and FDA 21 CFR Part 820; serve as audit SME.
• Use Minitab or equivalent for DOE, capability, SPC, Gage R&R, data analysis.
• Lead PFMEA, CAPA, and root cause investigations; apply structured problem-solving.
• Collaborate cross-functionally to align process improvements with business needs.
• Train production teams on validated processes and in-process monitoring.

Skills

DOE

Six Sigma

Minitab

Gage R&R

SPC

CAPA

Root Cause Analysis

Lean Manufacturing

Leadership

Education

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

Tools

Minitab

Job description

Crosslinked is seeking a Senior Process Engineer for its Providence, RI location to validate and optimize thermoforming and heat-sealing processes for medical device packaging components. You will lead IQ/OQ/PQ validation activities, define CPPs/NOR, and drive continuous improvement across Operations, Quality, and Design teams.

The role requires 3–5+ years in a regulated environment, working knowledge of ISO 13485 and FDA 21 CFR Part 820, and strong DOE/Six Sigma capabilities.