Job Description

Job ID: 618582

***Please Note: This is an onsite role in North Haven, CT - Please only apply if you either local to the area or plan to relocate without monetary assistance***

Our client, a leading Medical Device company, is seeking an experienced Manufacturing Engineer who will be responsible for validating and qualifying new packaging materials (foil, Tyvek, film) for absorbable suture products. This roles will also assist with process development activities and creating the validation plans in compliance with company standards. See below for other details:

Top 3 Skills Needed:

1. Packaging Experience
2. Validation Experience – Process Development, OQ, IQ, PQ
3. Familiarity with Cognex and Keyence based vision inspection systems

Responsibilities:

• Designs manufacturing processes procedures and production layouts for assemblies equipment installation processing machining and material handling.
• Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
• Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
• Adapts machine or equipment design to factory and production conditions.
• May incorporate inspection and test requirements into the production plan. Inspects performance of machinery equipment and tools to verify their efficiency and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Develops manufacturing processes that are applicable to statistical process control and may develop those techniques.
• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Ensures processes and procedures are in compliance with regulations.

Requirements:

Bachelor's Degree with 2-5 years of experience

Nice To Have:

1. 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.
2. 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.
3. Strong working knowledge of FDA Medical Devices Part 820 Quality System (QS) Regulation & Medical Device Good Manufacturing Practices

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