Packaging Engineer for Medical Device Validation

6 days ago


North Haven, Connecticut, United States Entegee Full time

Entegee is a leading provider of custom automation solutions, and we are currently seeking an experienced Packaging Engineer to lead validations of medical device packaging systems.

This role will involve performing gap analyses, developing innovative packaging solutions in compliance with ISO standards, and ensuring compliance with industry practices.

We offer a competitive salary range of $50-$65 per hour, plus benefits that include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits, and a 401K plan.

Responsibilities
  • Lead validation of packaging systems for medical devices
  • Conduct evaluations of medical device product packaging design; perform gap analysis to the latest industry standards, including ISO11607 Part 1 and 2
  • Generate and execute packaging remediation plans for sterile and non-sterile medical device packaging, including protocol creation, execution, and documentation updates
  • Identify and develop innovative packaging processes and designs, determining specifications based on product needs, cost, and regulatory requirements
  • Support regulatory audits, draft technical responses, and ensure compliance with industry practices
  • Lead project meetings and provide updates to management
  • Assist in the labeling development process

Please note that we consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements.


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