Manufacturing Engineer II - Exempt

Manufacturing Engineer

The Manufacturing Engineer will be responsible for validating and qualifying new packaging materials (foil, Tyvek, film) for absorbable suture products. This role involves process development activities and creating validation plans in compliance with company standards. The engineer will be the project lead and communicate project deliverables and timing to engineering management.

• Packaging Experience
• Validation Experience – Process Development, OQ, IQ, PQ
• Familiarity with Cognex and Keyence based vision inspection systems

Education Required:

BS (or above) in Engineering;
Mechanical, Manufacturing, Packaging

Years' Experience

Required:

3-5

Will the contractor be working 40 hours a week? Yes, 40 hours/week.

Onsite Requirement:
Required to be onsite full time.

Interviews to start as soon as possible.

This position will support the GST Focus Factory, specifically validating and qualifying new nylon film for our absorbable suture products.

• 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 the 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.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

• Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects/assignments.
• Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross-functional assignments.
• Innovation and Complexity: Problems and issues faced are general and may require understanding of a broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve the effectiveness of the job area.
• Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem-solving in nature. Contacts others to share information, status, needs, and issues to inform, gain input, and support decision-making.
• Leadership and Talent Management: May provide guidance and assistance to entry-level professionals and/or employees in the Support Career Stream.

Requires practical knowledge and demonstrated competence within the job area typically obtained through advanced education combined with experience. Requires a University Degree and a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience.

• 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.