Senior Packaging Innovator

5 days ago


North Haven, Connecticut, United States Entegee Full time

Job Summary: We are seeking an experienced Senior Packaging Innovator to lead validations of medical device packaging systems, perform gap analyses, and develop innovative packaging solutions in compliance with ISO standards.

About Entegee: As a leader in custom automation projects, we specialize in controls and robotic solutions globally. Our team is committed to expanding your skills and building you into a top-performing engineer.

Salary and Benefits

The estimated salary for this position is $55.00 per hour. Additionally, our benefit offerings 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.
Requirements
  • Bachelor's degree 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.

A competitive compensation package will be offered to the selected candidate.



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