Sr Packaging Engineer

North Haven, Connecticut Mechanical Engineering 7 days ago

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Job Posting Summary:

Seeking a Packaging Engineer to lead validations of medical device packaging systems, perform gap analyses, and develop innovative packaging solutions in compliance with ISO standards.

Job Requirements:

  • BS in Packaging Science or Mechanical Engineering
  • 5+ years of experience in medical device or pharmaceutical industry packaging
  • Knowledge of ISO 11607 Part 1 and 2, ASTM, and ISTA package test methods

Job Preferred Skills:

  • Experience with packaging systems gap analysis in accordance with ISO11607 Part 1 and 2

Job 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


Pay Details: $50.00 to $65.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
  • The California Fair Chance Act
  • Los Angeles City Fair Chance Ordinance
  • Los Angeles County Fair Chance Ordinance for Employers
  • San Francisco Fair Chance Ordinance
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