Senior Packaging Development Engineer

Katalyst CRO; North Haven (CT); On-site; USD 80,000 - 100,000; Full time

Job summary

Katalyst CRO is seeking a Sr. Packaging Engineer in North Haven, Connecticut to provide technical leadership in packaging development and validation. The role involves evaluating current medical device packaging designs, conducting gap analyses, and ensuring compliance with quality and regulatory requirements.

The ideal candidate will have a Bachelor's degree in engineering and at least 5 years of experience in medical device or pharma packaging, as well as experience with ISO11607 and leading project meetings.

Qualifications

• 5+ years of medical device or pharma packaging experience.
• Experience leading project meetings to track progress and updates.

Responsibilities

• Evaluate current packaging design and perform gap analysis.
• Generate remediation plans for packaging systems.
• Lead validation of packaging systems for medical devices.
• Identify and develop innovative packaging processes.

Skills

Gap Analysis

Validation of Packaging Systems

ISO11607 Compliance

Project Management

Education

Bachelor's degree in engineering

Job description

Summary

The Sr. Packaging Engineer provides technical leadership for packaging development and validation, ensuring products meet quality and regulatory requirements while driving process improvements and supporting cross‑functional initiatives.

Roles & Responsibilities

• Evaluate the current state of various medical device product packaging design; perform gap analysis on existing studies to the latest industry standards such as ISO11607 Part 1 and 2.
• Generate and execute packaging remediation plans for sterile barrier systems and non‑sterile medical device packaging. Define remediation plans, generate/execute protocols, author closing reports, update specifications and technical documentation.
• Lead successful validation of packaging systems for medical devices.
• Identify and develop innovative packaging processes and designs as part of a cross‑functional team. Determine packaging specifications according to the nature of the product, cost limitations, legal requirements, and type of device protection required.
• Utilize quality and regulatory compliance knowledge to support regulatory body audits, draft technical responses and provide innovative ideas to ensure compliance to latest industry practices.
• Lead project meetings and provide updates to management.
• Assist in labeling development process.

Education & Experience

• Bachelor's degree in engineering
• 5+ years of medical device or pharma packaging experience
• Validation of Packaging Systems
• Gap Analysis
• ISO11607
• Ability to conduct Packaging systems Gap Analysis according to ISO11607 Part 1
• Experience leading project meetings