Job Description :
Project Manager (FDA, Medical Manufacturing Plant)
Location: Sunnyvale , CA
Duration: 6 Months Contract To hire

Job Description
Supports variety of change management initiatives in business unit.
Part of service unit Robotic surgery platform 4th or 5th generation.
Installation , repair , service monitoring. Help facility change of service business unit.
Focusing in supporting introduction opening of new building for new logistic unit.
Around the globe for commercial for meeting revenue and service aspect of logistic fail in the field, replacement.
From warehousing prospective
Business readiness aspect and implementation of new finished goods in Sunnyvale. Not responsible for constructions
Coordination of various resources planning, IT Team, Compliance and regulatory, managing the goods and letting them know the risk.
Development for IT and registrations for the compliance.
Some direct or indirect transition. Global company not direct in all countries have distribution partners across the globe.
That is project as well handling and observing the distribution and getting the distribution onboarded with processing orders. This is add on.
Work on IT projects. Building with compliance with regulatory.

Must Have :
Logistic team and qualifying from regulatory perspective and all the requirements that are needed.
Manufacturing experience. Medical device will be huge plus. Regulation from FDA outside of US and complexity to navigate through all those.
FDA regulation for medical device is required.
Service operations/Manufacturing side.
They will be managing business projects dealing with sales operation, logistic, Material handling.
Capital equipment will be nice to have. Not more on Robotics.
Have you established for Medical manufacturing plant or moved the medical manufacturing plant. (must have)
Moved the repair line or opened warehousing plant. (Must have

Skill/Job Requirements:
Four year degree (Bachelor’s degree or global equivalent) in a scientific field preferred, business, finance or related field will be considered in conjunction with experience
Certification in project management (PMP) desired
Proven record of bringing products to market acting as project leader on behalf of Field Service/Service Operations, and/or experience in support of medical device Manufacturing group supporting line transfers
3-5 years’ experience supporting complex capital equipment (medical devices and/or robotics preferred), including mechanical, electrical, and software elements containing a large number of SKUs
Experience working in support of a Field Service and/or Technical Support organization preferred (Not required)
Demonstrated experience influencing product development on behalf of service, familiarity with Design For Serviceability/Maintenance (DFS/DFM) principles and practices
Strong project management, planning, decision making, negotiating and change management skills
Ability to promote ideas persuasively, influence others, and build and maintain effective professional relationships with internal partners and business leaders
Strong relationship building, customer focus and facilitation skills
Great writer and talker. Can organize, summarize, clarify and communicate ideas simply, succinctly, and accurately to engineering and non-technical audiences.
Pragmatic, organized and detailed. Has a big capacity to both think and do, strong on detail and highly organized.
An independent thinker willing and able to express and support a point of view.
Has a quick intelligence, is fast on their feet and quickly responds to issues and questions.
Capable of maintaining a rapid pace: moves at a nice clip and enjoys having multiple projects going at once. Can change course, be scrappy and get things done on short time frames.
Primary Function of Position:
The Project Manager is responsible for providing cross-functional project management on behalf of the Services business unit in support of launching new product introductions, leading major manufacturing or repair line transfers, and executing on key strategic initiatives.
The Project Management team serves as the primary liaison between ISI''s Engineering PMO and the Services business unit teams supporting the product. With the development and introduction of new products, the Project Manager identifies service strategies, service requirements, risks, deliverables, schedules, and leads the cross-functional effort to execute the project plan. In addition to NPI support, the Project Manager provides tactical project management leadership to key operational strategic initiatives, including line transfers and recalls/product upgrades.
The success of the Program Management team is mission critical to the success of the worldwide Services business unit. This is where your leadership, hands-on experience supporting global service organizations, fascination with robotics, and your passion for leading change within a complex, fast-paced, highly regulated environment can make a direct impact.