• Us Citizen

• Green Card

• Corp-Corp

• Consulting/Contract

• UG :- - Not Required

• PG :- - Not Required

• No of position :- ( 1 )

• Post :- 30th Apr 2021

o    Drive the development of new medical device development programs through project completion within timeline, quality and budgetary limits
o    Lead and integrate cross-functional teams and manage deliverables in a matrix organization
o    Lead, manage and direct the development and execution of integrated project plans relevant to the deliverables and ensure alignment across relevant functions and a smooth transition among pipeline stages
o    Manage multiple projects across several departments while influencing project decisions in coordination with Medical Affairs, R&D, Clinical, Regulatory Affairs, Quality, Manufacturing and Logistics timelines.
o    Identify and implement solutions to improve tracking, planning and collaboration
o    Ability to gain cooperation of others and effectively facilitates cross-functional meetings and discussions
o    Ensure effective, accurate and timely communication across functional areas
o    Serve as a primary point of contact for management regarding progress and goals
o    Work with the team leaders to identify and resolve any team and individual performance issues
o    Bring a broadened business perspective to each project through an understanding of the inner-workings of Marketing, Quality, R&D, Finance, Regulatory, Manufacturing, Clinical, Medical Affairs, and Operations.
o    Managing and coordinating the activities of a multi-disciplined project from concept to commercialization.  Plan, develop, coordinate and direct engineers and other cross-functional team members to achieve project objectives.

Qualifications:
o    Bachelor's degree or equivalent experience in related field required
o    A minimum of 7+ years related work experience required
o    Bachelor's degree in Mechanical Engineering, Chemical Engineering, Electrical Engineering or related field required. Advanced degree in related field or business preferred.
o    A minimum of 13+ years related work experience required in device and/or drug development and project management within the device/pharmaceutical industry, or reasonable combination of the two.
o    Must have a strong familiarity with the integration of requirements and deliverables associated with Design Controls (21CFR820.30) into the new product development process.
o    Must have experience with short release cycles.
o    Demonstrated success in large Project/Program Management role including Development and Deployment, preferably healthcare, or closely related is a plus.
o    Experience leading large global programs.
o    Experience managing ambiguity and providing clarity for teams.
o    Demonstrated learning agility of new subject matter.
o    Excellent interpersonal, communication, presentation and influencing skills
o    Global product development and team management experience is a plus.
o    Experience working in a highly government-regulated environment (FDA, MHRA, EMEA, TGA, etc.). Must have led a cross-functional project team through regulatory submission and product commercialization