What are the responsibilities and job description for the Manufacturing Engineer II position at Grove Technical Resources, INC?
Job Title - Manufacturing Engineer II
Job Location - North Haven, Connecticut
Job Description -
The ME will be responsible for validating and qualifying new packaging materials (foil, Tyvek, film) for absorbable suture products. The ME will be responsible for process development activities and creating the validation plans in compliance with company standards. The ME will be the project lead and communicate project deliverables and timing to engineering management.
Nice To Have
- 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 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
Top 3 technical skills that are required for the role:
- Packaging Experience
- Validation Experience – Process Development, OQ, IQ, PQ
- Familiarity with Cognex and Keyence based vision inspection systems
Responsibilities may include the following and other duties may be assigned.
- 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 a most efficient and productive layout.
- Designs sequence of operations and specify 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.
- Ensuring processes and procedures are in compliance with regulations.
