Director - Manufacturing - Leaf Healthcare - San Francisco

Job description
We are presently recruiting to fill a Director of Manufacturing position, reporting directly to the CEO, in our soon to open Pleasanton, CA facility. In this role, you will be responsible for the manufacture of our Patient Monitoring System, a medical device comprised of disposal, wearable, electronic patient sensors, and durable RF networking components. You must have experience with manufacturing compliant with FDA’s cGMP (or at the minimum, with well-controlled manufacturing consistent with a quality system similar to the FDA’s QSR, ISO 13485, or ISO 9001). You must be familiar with creating and maintaining Work Instructions, BOMs, and Work Orders. You must have experience in all aspects of manufacturing operations: materials planning and procurement, receiving, inventory management, process development, assembly, manufacturing testing, packaging, and ship in/out. Experience with manufacturing systems such as MRP/ERP is desirable. You must have experience hiring and supervising manufacturing personnel, including assemblers and manufacturing engineers. You must be a collaborative worker who thrives on cooperation among manufacturing, engineering, sales, and clinical/regulatory/quality assurance.

Responsibilities:
Manage and continue to build manufacturing team.
Continue the development of and oversee a cGMP compliant electronic device assembly facility, its systems and procedures.
Maintain OEM manufacturing relationships with sub-assembly suppliers.
Create and maintain BOMs, Work Instructions, approved supplier lists, and inspection criteria.
Cooperate with and share goals with Sales, Marketing, Design and Quality Engineering in the timely scoping, development, delivery and support of new and ongoing product offerings.
Ensure Work Orders, Travelers, Assembly, and Testing procedures and forms are completed properly and accurately.
Desired Skills and Experience
Requirements:
Minimum 5 years manufacturing management experience (electro-mechanical device experience preferred), including supervision of foreign and domestic manufacturing partners, manufacturing engineering, and quality engineering departments and activities.
Familiarity with all manufacturing activities: materials planning and procurement, receiving, inventory management, process development, assembly, test, packaging, ship in/out.
Additional skills and abilities to perform the job include: strong analytical skills; strong oral and written communication skills; detail oriented; strong computer literacy skills; exercises mature judgment; ability to work with and /or lead a team of engineers and technicians; ability to work independently; ability to influence other people; ability to act as a mentor; project management experience.

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