Associate Director leading cross-functional medical device projects at BD. Overseeing project execution and mentoring teams in a global context.
Responsibilities
Effectively prioritize and coordinate all sustaining projects within the Advanced Access Devices (AAD) portfolio.
Manage and communicate project and portfolio metrics to the AAD and MDS Leadership Teams.
Coach and mentor junior project managers on best practices that deliver on-time and predictable execution.
Develop project/portfolio management processes and tools to provide strategic direction that effectively drives critical to the business projects.
Collaborate with cross-functional teams to ensure timely delivery, review and approvals via multiple regional registrations in addition to other conflicting/dependent programs.
Responsible for the execution, quality, and results of the projects and the success of the resulting products for the business or in the market.
Interact with functional managers and business leaders to communicate critical project risks, mitigations, questions and/or challenges.
Define program resource needs and negotiate program resourcing plans.
Work with functional leaders to ensure the appropriate core team resources are committed to the program and contribute to the required performance levels.
Mentor, coach and challenge core team members, functional leaders and business leaders regarding functional and cross functional strategies and approaches to improve program development outcomes.
Analyze development situations and data with in-depth evaluation of multiple factors.
Influence solutions to business or technical problems.
Communicate and implement the strategic and technical direction for the project/program teams.
Requirements
BS degree in engineering (required)
At least 10 years relevant experience in medical device product development and design
3+ years of experience leading medical device cross-functional, global teams through complex projects or programs
Sustaining and/or remediation experience with Class II medical devices
Successful launch experience of medical device products from concept through launch
Medical Device, Program management experience (beyond just project management)
Ability to develop technical and business process solutions to complex problems
Knowledge of global medical device regulatory requirements (FDA, Anvisa, NMPA, MDR) and quality standards (ISO, GB, JISC)
Complete understanding of medical device project management principles, theories & concepts
Experience with creating work breakdown structures, risk management, and integrated business plans
Thorough understanding of functional work streams in a phase gate process
Experience in medical device product development planning, risk identification, and timeline optimization
Experience leading development of commercialization strategies
Excellent interpersonal, communication, presentation and influencing skills.
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