Packaging Engineer II - Medical Device

Title: Packaging Engineer II – Medical Device

Location: North Haven, CT

Pay Rate: $55/hr on W2

Job Description:

• We are hiring a Packaging Engineer II with experience in medical device packaging, process validation, and packaging qualification to support the development and validation of packaging systems for absorbable suture products.
• The ideal candidate will have hands-on experience with Tyvek, foil, film packaging materials, IQ/OQ/PQ validation, equipment qualification, and process development in a regulated manufacturing environment.

Responsibilities:

• Develop, validate, and qualify packaging materials and processes.
• Execute packaging validation activities including IQ, OQ, PQ, and process validation lifecycle.
• Create validation protocols, reports, SOPs, and engineering documentation.
• Support packaging design, testing, and manufacturing process improvements.
• Lead cross-functional projects and communicate project status to engineering leadership.
• Support vision inspection systems including Cognex and Keyence.
• Manage engineering changes and documentation within a GMP environment.

Required Skills:

• Bachelor’s degree in Mechanical, Manufacturing, Packaging Engineering, or related field.
• 3–5 years of packaging engineering experience.
• Experience with medical device packaging validation.
• Strong knowledge of IQ/OQ/PQ, process validation, and equipment qualification.
• Experience with sterile packaging materials (Tyvek, foil, film).
• Familiarity with FDA 21 CFR Part 820, ISO 13485, and GMP requirements.
• Experience with DOE/Minitab is a plus.

Preferred Background:

• Medical device, pharmaceutical, or life sciences manufacturing experience.
• Experience with packaging inspection systems and validation documentation.
• Strong communication skills and ability to collaborate with Engineering, Quality, Manufacturing, and Regulatory teams.