Role: Packaging Engineer II (Medical Device)
Location: North Haven, CT (Onsite – 5 Days/Week)
Employment Type: W2 Contract
Durtion: Aug 2026 – Apr 2027
We are seeking a Packaging Engineer II with experience in medical device packaging validation, process validation, and packaging development. This role will focus on validating and qualifying new packaging materials for absorbable suture products while ensuring compliance with FDA and ISO standards.
Top Required Skills
Packaging Engineering
Process Validation (IQ, OQ, PQ)
Packaging Validation & Qualification
Process Development
Equipment Qualification (IQ)
Packaging Materials (Tyvek, Foil, Nylon Film, Flexible Films)
Cognex & Keyence Vision Inspection Systems
Project Leadership & Cross-Functional Collaboration
Key Responsibilities
· Lead packaging validation for new packaging materials.
· Perform Equipment Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
· Execute the complete Process Validation Lifecycle, from process characterization through PQ.
· Develop validation protocols, reports, and engineering documentation.
· Support packaging process development and continuous improvement initiatives.
· Work with Cognex and Keyence vision inspection systems.
· Create SOPs, support change control activities, and ensure GMP compliance.
· Collaborate with Manufacturing, Quality, Validation, and R&D teams to deliver projects on time.
Required Qualifications
· Bachelor's Degree in Packaging, Mechanical, Manufacturing, or related Engineering.
· 3–5 years of experience in:
o Packaging Engineering
o Medical Device Manufacturing
o Process Validation
o Packaging Validation
Equipment Qualification
· Experience with IQ, OQ, PQ, process development, and validation documentation.
Preferred Skills
DOE (Design of Experiments) using Minitab
Computer System Validation (CSV)
SOP Development
Medical Device Change Control
FDA 21 CFR Part 820
EU MDR (2017/745)
ISO 13485, ISO 14971, IEC 60601
GMP Documentation
Microsoft Office (Excel, Word, PowerPoint)
Keywords
Packaging Engineer | Medical Device | Packaging Validation | Process Validation | IQ | OQ | PQ | Equipment Qualification | Packaging Development | Tyvek | Foil | Nylon Film | Cognex | Keyence | DOE | Minitab | CSV | SOP | GMP | FDA 21 CFR Part 820 | ISO 13485 | EU MDR | Change Control | Manufacturing Engineering
Pay: $40.40 - $45.35 per hour
Work Location: In person
