18 Jun
Engineering Program/Project Mgmt
Vacancy expired!
- Drive the development of medical device development programs through regulatory submission within timeline, quality, and budgetary limits
- Lead and integrate cross-functional teams and manage deliverables and decision making in a matrix organization
- 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
- Manage multiple projects while influencing project decisions in coordination with Marketing, Medical Affairs, R&D, Clinical, Regulatory Affairs, Quality, Manufacturing and Logistics
- Identify and implement solutions to improve tracking, planning, and collaboration
- Ability to gain cooperation of others and effectively facilitates cross-functional meetings and discussions
- Ensure effective, accurate and timely communication across functional areas and matrix
- Serve as a primary point of contact for management regarding progress and goals
- Work with the functional leaders to identify and resolve any team and individual performance issues
- 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
- A minimum of a bachelor's degree
- A minimum of 3-5 years of Project Management experience
- A minimum of 7+ years related work experience in product development.
- Demonstrated success in Project Management roles including Development and Regulatory Submissions, preferably healthcare, or closely related is a plus
- Experience leading large programs with distributed teams and leadership
- Excellent interpersonal, communication, presentation and influencing skills
- PMP certification
- High volume device and/or drug development and project management within the medical device/pharmaceutical industry, or reasonable combination of the two
- Strong familiarity with the integration of requirements and deliverables associated with Design Controls (21CFR820.30) into the product development process
- Experience with short release cycles
- Experience managing ambiguity and providing clarity for teams
- Experience working in a highly government-regulated environment (FDA, MDR).
- Experience leading a cross-functional project team through regulatory submission and product commercialization
- Demonstrated learning agility of new subject matter
Vacancy expired!