Sr Packaging Engineer

Job Description

Job Description

Job Title:         Sr Packaging Engineer

Location:         Lafayette, CO 80026

Duration:         12+ Months with possible extension or conversion

Pay Rate:         $60 - $65/hr on W2

Job Description:

• Sr. Packaging Engineer supporting the CST business unit. This contractor will lead and support packaging-related work tied to manufacturing transfer, process validation, design verification in a regulated medical device environment.
• Day-to-day responsibilities include collaborating with R&D, manufacturing, quality, and supply chain teams; developing and executing packaging test protocols and reports; supporting validation and verification documentation; evaluating packaging changes and associated technical rationale; and ensuring compliance with FDA and EU MDR expectations.

Must Have:

• Change control of Medical Devices
• Equipment Commissioning / Qualification
• Process Validation
• Computer System Validation (CSV)
• Manufacturing, Packaging and Laboratory Equipment
• Technical experience (Trouble shooting) or any similar experience or background
• Quality / Process Control / Assurance of Medical Devices
• Design and development of a packaging system for terminally sterilized medical devices as per requirements established by ISO 11607-1 (Part 1: Requirements for materials, sterile barrier systems and packaging systems) and corresponding packaging ASTM and ISTA (International Safe Transit Association) standards.
• Validation of processes for packaging medical devices that are terminally sterilized as per requirements established by ISO 11607 2 (Part 2: Validation requirements for forming, sealing and assembly processes).
• These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
• Strong working knowledge of FDA Medical Devices Part 820 Quality System (QS) Regulation & Medical Device Good Manufacturing Practices
• Experience in equipment IQ Process Validation Lifecycle (from process characterization, OQ to PQ)
• 5 years experience with a BS Packaging or related engineering field or 3 years with MS
• Sterile Barrier Testing

Nice To Have:

• 3D Modeling
• Applied Minitab analysis
• cost savings analysis

Top 3 technical skills:

• Packaging engineering experience in regulated medical device or other regulated industries
• Manufacturing transfer, process validation, and design verification experience
• Working knowledge of FDA and EU MDR requirements, including technical documentation and justification support

Education required: Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or related technical field.

Years’ experience required: Typically 5 to 8 years of relevant packaging engineering experience, with strong preference for experience in regulated medical device environments.

Product line will this person support : CST business unit product line, focusing on the Enabling Technologies products

Responsibilities:

• Designs, develops, and tests a wide variety of containers used for the protection, display, and handling of products.
• Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering.
• Designs package exteriors considering such factors as product identification, sales appeal, aesthetic quality, printing and production techniques.
• Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants