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Senior Equipment Engineer

Company Name:
Premier Personnel Services of New York
SUMMARY DESCRIPTION
Responsible for functional management of the Equipment Engineering Group in support of manufacturing equipment design, development, and implementation associated with Collagen Manufacturing Operations. This position is responsible for ensuring that manufacturing equipment development projects result in complaint and robust equipment implementations for existing products and new products. This position will be responsible to ensuring a disciplined equipment development process is developed and followed. Responsible for maintaining and where applicable managing and developing external equipment supplier relationships and partnerships. This position will have 4-6 Equipment Engineers as direct reports.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Responsible for leading manufacturing equipment engineering related activities to support existing product site transfers and new product commercialization. Work with key stakeholders in Ops to identify and manage new equipment and equipment improvement projects for collagen manufacturing.
Drive improvements in the Equipment Engineering Group through the wide implementation and use of equipment development processes and roadmaps to ensure robust and efficient development of custom manufacturing equipment.
Provide technical leadership working internally and with external suppliers to deliver custom manufacturing equipment solutions (manual, semi-automate, and automated) that will robustly and compliantly manufacture Companys Collagen based products.
Provide leadership to timely technical investigations and techniques to identify potential root causes of manufacturing issues and provide leadership in proposing robust short and long term corrective actions when necessary.
Ensure that Design Control Processes are followed when applicable.
Provide technical leadership in the development and mentoring of the Equipment Engineering team.
Interface and partner with Product Development and Operations to ensure alignment on Equipment improvements, development, and characterization activities.
Lead, support, and participate on special operations improvement projects as needed.
Provide technical leadership for processes changes, NCs, and CAPA related activities.
Minimum BS in Mechanical, Electrical, or Controls Engineering discipline.
Minimum 10 years of experience in a medical device or pharmaceutical industry.
Minimum 5 years of direct experience in the custom automated manufacturing equipment development.
Previous direct management experience of Engineers required. 7-10 years preferred.
Experience with Quality System Regulation (QSR), Design Control and Process Validation guidelines, Engineering Change Controls, QSR, ISO, and Design Control and Regulatory procedures is required
Experience with custom manufacturing equipment development using outside suppliers.
General Engineering, chemistry, processing, and materials expertise desired.
Exceptional practical problem solving, organizational and communication skills,
Microsoft Office software and tools

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