Job Description Summary

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.

• Lead cross-functional team in a highly regulated industry.
• Manage all activities of the Product Development Process phases: Concept, Feasibility, Development, Qualification and Launch
• Develop project plan, risk-based timeline and budget to support project goals, including coordination, tracking and monitoring activities
• Lead cross-functional teams through identification of risks & mitigations, problem resolution and root cause analysis, corrective and preventive action.
• Manage project communications to all stakeholders (project teams, functional managers, and senior management), including meeting minutes, monthly updates, communications meetings, and phase reviews.
• Ensuring compliance with quality management systems and regulatory requirements, where applicable.
• Facilitating the exchange of information between departments on a day-to-day basis and maintaining liaison with all members of the project team between project team.
• Lead the team to prepare for and execute Phase Gate. Represent the team with BD leaders, ensuring such decisions are informed by a balanced and clearly articulated representation of the relevant data.
• Develop a mentality of collaboration, execution, and continuous improvement within the program through these mechanisms.
• Collaborate and act as the key liaison between cross-functional and external vendors.
• Experience in medical device industries required, including experience in FDA or other regulated environments.
• Knowledge of the medical device industries beneficial integrating science and technology into business processes.
• Exceptional analytical, critical thinking and problem-solving skills coupled to strong business, strategic and financial acumen.
• Responsible for driving design control requirement during the product development.

• Experience in medical device industries required, including experience in FDA or other regulated environments. Knowledge of the medical device industries beneficial integrating science and technology into business processes.
• Exceptional analytical, critical thinking and problem-solving skills coupled to strong business, strategic and financial knowledge.
• Ability to communicate clearly and concisely to all levels of the organization, spanning cross-functional teams to business leadership.
• Expert in cross functional/cross-sites/external strategic partner team leadership delivering critical business goals within a phase-gate based product development process.
• Expert in the development and deployment of program management tools and techniques including methods for tracking progress, risk management and delivery of major milestones.
• Excellent influencing skills with the ability to achieve challenging goals through others without direct authority across different functions, external partners, geographies, and cultures. Drive for accountability within self and others.
• Time management, self-control, continuous learning, drives for order yet flexible and nimble. Versatility of thought and action in unanticipated circumstances using structured tools at his/her disposal to respond effectively and resolve unanticipated changes.
• Relentless advocacy for the customer with a focus on meeting or exceeding customer requirements. Driving the team to make trade-offs that optimize customer and business value while maintaining program velocity and outcomes that sustain the highest standards of quality.
• Proven project management experience with delivering medium-to large-scale projects in managed service model from concept through delivery and operations
• Ability to think creatively about where business initiatives drive technology evaluation and to break-down process and reimagine enabling technology capabilities
• Excellent written and oral communication skills, strong negotiating/influencing skills and willing to work with minimal supervision
• Design control for medical device, software and product life cycle managment

• Bachelor's degree in Science or Engineering related is required.
• Scrum Master and SAFE Agile certification is preferred
• Minimum of 6-8 years of experience in successfully leading complex, multiyear new product development programs delivered through high performing cross-functional teams based in a matrix organization.
• Project Management Professional (PMP) certification not required but is a preferred
• Knowledge and experience working in a highly FDA regulated industry.
• Deep understanding of translating customer requirements into technical requirements.
• Strong analytical and problem-solving skills.
• Willing to travel up to 20%