Senior Packaging Engineer - Medical Device Validation

Intellectt Inc; North Haven (CT); On-site; USD 55,000 - 62,000; Full time

Benefits offered by this job

Health insurance

401(k) retirement plan

Paid time off as required by law

Job summary

Intellectt Inc is seeking an experienced Packaging Engineer to lead packaging process development for medical device manufacturing. You will qualify equipment (IQ/OQ/PQ), drive improvements, and collaborate with Manufacturing, Quality, Regulatory, Operations, and Engineering teams.

A Bachelor's degree in packaging or related engineering and 7+ years of experience in regulated environments are required; Lean/Six Sigma experience is a plus.

Qualifications

• Bachelor's degree in packaging/engineering required.
• 7+ years of Packaging Engineering experience in regulated environments preferred.
• Knowledge of packaging validation, manufacturing processes, quality systems, and regulatory requirements.

Responsibilities

• Support and improve packaging operations for medical device manufacturing.
• Lead packaging process development, equipment qualification, and validation activities (IQ/OQ/PQ).
• Collaborate with Manufacturing, Quality, Regulatory, Operations, and Engineering to resolve issues and drive improvements.
• Perform root cause investigations and develop CAPA solutions; maintain technical documentation.

Skills

Problem solving

Project leadership

Technical communication

Cross-functional collaboration

Education

Bachelor's degree in Packaging Engineering / related Engineering

Job description

Intellectt Inc is seeking an experienced Packaging Engineer to lead packaging process development for medical device manufacturing. You will qualify equipment (IQ/OQ/PQ), drive improvements, and collaborate with Manufacturing, Quality, Regulatory, Operations, and Engineering teams.

A Bachelor's degree in packaging or related engineering and 7+ years of experience in regulated environments are required; Lean/Six Sigma experience is a plus.