R&D Program Manager

Becton Dickinson Medical DevicesSan Diego, CA
5dOnsite

About The Position

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. R&D Program Management, Infusion Reporting to the Associate Director, Product and Development, this Engineering Program Manager is responsible for overseeing and ensuring the success of multi-faceted and highly complex engineering program within the Medication Management Solutions (MMS) Infusion Platform at BD. This role will be responsible for driving alignment on technical strategy across embedded software, hardware and cloud-based software solutions. The individual in this role is expected to leverage best practices in cross functional team/external partnership leadership to drive excellence in areas such as product design and development, and full commercial launch. This role will also enable efficient and accurate management of resources, budgets, and project data to support strategic decision-making within the MMS Infusion Platform at BD. This role will be champion of design control and product life cycle management.

Requirements

  • 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
  • Understanding of engineering development lifecycles and the ability to translate technical inputs into program-level actions and timelines
  • Strong knowledge of design control for medical device, software and product life cycle management
  • Bachelor’s degree in Science or Engineering related is required.
  • 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.
  • 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%

Nice To Haves

  • Scrum Master and SAFE Agile certification is preferred
  • Project Management Professional (PMP) certification not required but is a preferred

Responsibilities

  • Lead cross functional team for complex medical device platform(s) and important sub-project(s) with responsibilities for large elements of the product development effort.
  • Identify technical integration dependencies between electrical, mechanical, software and systems disciplines
  • Lead technology transfer efforts to ensure design intent is appropriately deployed in an engineering production environment
  • Represent the engineering team in discussions with cross-functional partners, both within BD and externally
  • 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 technical challenges, risks & mitigations, problem resolution and root cause analysis, corrective and preventive action.
  • Manage project communications to all stakeholders (project teams, development teams, functional managers, and senior management), including meeting minutes, monthly updates, communications meetings, and phase reviews.
  • Ensuring engineering design is compliant 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.
  • Key member of the engineering team in charge of tracking product development progress, identify risks related to technical execution, and ensure alignment between engineering activities and program timelines.
  • Leverage technical engineering acumen to monitor development progress, and ensure alignment between technical deliverables and program timelines
  • Collaborate and act as the key liaison between cross-functional and external vendors. This effort ensure that suppliers meet technical requirements and production equivalent parts are adequately verified through systematic testing
  • Responsible for driving design control requirement during the product development.
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