Senior Packaging Engineer - Medical Device Packaging

Creative Solutions Services, LLC; North Haven (CT); On-site; USD 85,000 - 110,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an engineer to support and improve packaging operations for medical device manufacturing, leading process development, equipment qualification, and validation activities (IQ/OQ/PQ).

You will collaborate with Manufacturing, Quality, Regulatory, Operations, and Engineering to resolve production issues, implement continuous improvement, and ensure compliance with FDA quality systems. Strong problem solving and cross-functional leadership required.

Qualifications

• Bachelor’s degree in packaging/engineering and related field is required.
• Experience in regulated manufacturing environments preferred.
• Knowledge of packaging validation, 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 production issues and drive continuous improvement; ensure FDA and quality system compliance.

Skills

Lean Manufacturing

Six Sigma

Root Cause Analysis

CAPA

Cross-Functional Collaboration

Project Leadership

Technical Communication

Education

Bachelor's Degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Chemical Engineering, or related Engineering

Job description

Creative Solutions Services, LLC is seeking an engineer to support and improve packaging operations for medical device manufacturing, leading process development, equipment qualification, and validation activities (IQ/OQ/PQ).

You will collaborate with Manufacturing, Quality, Regulatory, Operations, and Engineering to resolve production issues, implement continuous improvement, and ensure compliance with FDA quality systems. Strong problem solving and cross-functional leadership required.