Director of Software Solutions creating sales strategies and enhancing software offerings at Border States. Leading teams, managing key relationships, and driving digital transformation efforts.
About the role
- 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.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development opportunities
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