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Manages projects of low to moderate complexity by leading cross functional teams. Analyzes development situations and data with in-depth evaluation of multiple factors. Influences solutions to business or technical problems. Communicates and implements the strategic and technical direction for the project team. Communicates project status to all stakeholders. Demonstrates a working knowledge of business & market growth drivers & trends. Complete understanding of a wide application of project management principles, theories & concepts.
Job Responsibility:
Lead a cross-functional team, including R&D, Quality, Regulatory, Medical, and Manufacturing resources in managing and executing projects in support of global medical products
Execute proper project planning, including identification of critical paths, risk identification and mitigation, and contingency planning, utilizing appropriate project management tools
Ensure effective and efficient regular formal and informal project communications
Lead and support execution of technical and/or cross-functional project work
Support the portfolio of current products in terms of quality and regulatory compliance, manufacturing, and supply continuity
Ensure implementation and rigor of BD product development processes and design control procedures
Demonstrate strong and clear accountability for operational and program success
Demonstrate leadership, learning agility, and action orientation when facing uncertainty
Motivate the team to achieve individual and program objectives
Ensure compliance with BD quality policies, procedures, and practices
Ensure compliance with all local, state, federal, and BD safety regulations, policies, and procedures
Organize regular project meetings , working with project leaders to determine optimal meeting agendas
Work with project leaders to collect information to clearly communicate current status to Leadership Level
Requirements:
At least 3-5 years relevant experience in product development and design with at least 1 year product development and design experience in medical devices
Demonstrated experience leading cross-functional teams to complete product development from design through clinical trials and regulatory approval following a structured, phase-gated, product development process
Experience in a regulated industry required, medical device experience required
Bachelor’s Degree or Master’s Degree in a technical field required
Program Management Professional Certificate Preferred
Nice to have:
Desired experience in high volume plastics consumable manufacture