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Sr. Manager of Operations
4 weeks ago
Sr. Manager of Operations (Medical Device)
The Client:
Our client is well-funded biomedical platform company aiming to deliver life-changing solutions to patients and their doctors. They design and develop state of the art Pulsed Electric Field Systems to achieve meaningful and lasting therapeutic outcomes for patients.
The Role:
This Director or Sr. Manager of Operations, Electrical and Capital Equipment, is responsible for the complete supply chain for capital equipment that supports the Company’s world-class therapies. This Director of Ops will work directly with Research and Development on new product concepts and development, provide leadership in determining manufacturing technologies and suppliers for new and existing product lines, and manage the overall capital equipment supply chain, including sustaining/supplier engineering, forecasting, pricing, supply and capacity management.
Key Responsibilities
- As a seasoned technical expert with a proven leadership track record, lead and manage the development of a world class supply chain for the Company’s line of innovative therapies.
- Collaborate closely with Research and Development to support next-generation product development.
- Coordinate engineering sustaining activities and supplier change requests for capital equipment with Research and Development, Quality, and Regulatory to ensure continuous product availability.
- Establish strategic material planning with contract manufacturers to ensure product delivery through entire product lifecycle from new product introduction to obsolescence. · Provide insight on new technologies, materials and manufacturing techniques that will drive innovation and patient outcomes.
- Support Finance for product costing, invoicing, and cash flow tracking.
- Provide insight on new technologies, materials and manufacturing techniques that will drive innovation and patient outcomes.
- Work with the Sales and Marketing Team to determine capacity, forecast and order planning to ensure continuous product availability worldwide.
- Keep abreast of global electronic supply trends, technologies and key suppliers.
- Provide thorough oversight of manufacturing documentation with the goal of supporting a manufacturing process fully compliant with the Galvanize Quality Management System (QMS), applicable standards and guidance (e.g. IEC62304).
- Provide Regulatory Affairs with technical input and concise documentation in support of regulatory submissions.
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