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BD (Becton, Dickinson and Company) Engineering Program Manager in Salt Lake City, Utah

Job Description SummaryBD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. One of the Business unit of BD is MDS (Medication Delivery Solutions) which has various products in its $3.5B portfolio viz Catheters, Hypodermic syringes, Flush syringes, IV sets and Infusion sets to name a few with market leadership on most of them. And we are constantly working to innovate our portfolio to serve our customers meet their clinical needs.

With recent changes in ISO standards on Luer compliance & EUMDR regulations , one of MDS’s most profitable business group VAD (Vascular Access Devices) with an annual revenue of $1.5B is looking for an energetic Program Manager who can help transition our entire product portfolio towards ISO 80369-7 and EUMDR compliance.

The successful candidate will be part of MDS PMO organization, reporting direct line into the MDS – COE & Lean Program Director. The position is located in BD’s Salt Lake City (Utah) site. The PM will be in charge of VAD ISO-Luer & EUMDR development compliance program. PM will have to manage the multi-functional activities of the program, lead the cross functional team (R&D, Supply Chain, Marketing, Quality, MA, Regulatory etc.) through their deliverable, own and execute the program plan.

This role requires the PM to collaborate and sync with other development projects already in flight in VAD BG, specifically this role requires close interaction with multiple suppliers (which are engaged with their products as part of our Kits) and ensuring joint collaboration with them towards compliance to ISO 80369-7

Job Description

BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. One of the Business unit of BD is MDS (Medication Delivery Solutions) which has various products in its $3.5B portfolio viz Catheters, Hypodermic syringes, Flush syringes, IV sets and Infusion sets to name a few with market leadership on most of them. And we are constantly working to innovate our portfolio to serve our customers meet their clinical needs.

With recent changes in ISO standards on Luer compliance & EUMDR regulations , one of MDS’s most profitable business group VAD ( Vascular Access Devices ) with an annual revenue of $1.5B is looking for an energetic Program Manager who can help transition our entire product portfolio towards ISO 80369-7 and EUMDR compliance.

The successful candidate will be part of MDS PMO organization, reporting direct line into the MDS – COE & Lean Program Director. The position is located in BD’s Salt Lake City (Utah) site. The PM will be in charge of VAD ISO-Luer & EUMDR development compliance program. PM will have to manage the multi-functional activities of the program, lead the cross functional team (R&D, Supply Chain, Marketing, Quality, MA, Regulatory etc.) through their deliverable, own and execute the program plan .

This role requires the PM to collaborate and sync with other development projects already in flight in VAD BG, specifically this role requires close interaction with multiple suppliers (which are engaged with their products as part of our Kits) and ensuring joint collaboration with them towards compliance to ISO 80369-7.

The PM will be responsible for creating and implementing streamlined processes and tools for projectinitiation;prioritization and resource allocation; milestone tracking and reporting; and overall project governance & execution per plan.

Experience

  • Applies extensive technical expertise & has full knowledge of related disciplines. Develops technical and business process solutions to complex problems which requires out of the box thinking and creativity. In partnership with the platform and core team members, leads the development and commercialization, go to market and launch strategy for the project(s).

  • Responsible for the creation of the project work breakdown structures, risk management, integrated business plans and product requirements. Leads the cross functional development of product architecture for each functional area, synthesizes functional plans and identifies critical interdependencies to drive successful execution of the project.

  • Technical and business skills and judgment to significantly influence the direction of the project in right context. Able to create and influence novel thinking of the team.

  • Ability to communicate complex technical and business issues completely, concisely, and effectively to enable high-quality decision making and drive cross-functional alignment.

  • Has a thorough understanding of all functional work streams in a phase gate process and a vision of an integrated project plan.

  • Finds and creates new avenues of excellence. Self-starting and will take action without prompting or direction from others to solve problems.

  • Constantly looks for improvements in work processes and results by anticipating and dealing with problems and encouraging others to suggest innovations and improvements

  • Represents the organization as the prime contact on contracts and projects. Interacts with senior external personnel on significant technical matters often requiring coordination between organizations.

Scope of Responsibility

  • Create and effectively manage ISO luer 80369-7 & EUMDR compliance Program along with VAD R&D /cross functional leadership team.

  • Collaborates with cross functional team to ensure timely delivery, review and approvals via multiple regional registrations as well as other conflicting/dependent programs.

  • Responsible for the execution, quality and results of the project and the success of the resulting product for the business or in the market.

  • Interacts with functional managers and business leaders to communicate regarding critical project risks, questions or challenges.

  • Challenges core team members, functional leaders and business leaders regarding functional and cross functional strategies and approaches in order to improve program development outcomes.

  • Analyzes development situations and data with in-depth evaluation of multiple factors.

  • Influences solutions to business or technical problems especially in the context of Kit components and suppliers adhering to ISO 80369-7 & EUMDR.

  • Communicates and implements the strategic and technical direction for the project/program team.

  • Complete understanding of a wide application of project management principles, theories & concepts.

Requirements:

  • BS degree in Mechanical Engineering, Materials Science & Engineering, Biomedical Engineering or a closely related engineering degree is required. An advanced degree in an engineering discipline or MBA is preferred.

  • At least 6-8 years relevant experience in product development and design is needed.

  • 5+ years of experience leading cross-functional, global teams through complex projects or programs. Program management experience preferred.

  • Experience in new product development planning multiple work-streams, identifying risk and implementing action plans to optimize timelines and reduce execution risk.

  • Experience establishing customer requirements from defined needs specifications and translating to product requirements.

  • Excellent interpersonal, communication, presentation and influencing skills.

Preferred Skills:

  • PMP certification or equivalent.

  • Knowledge of global regulatory (FDA, Anvisa, NMPA, MDR) and quality requirements (ISO, GB, JISC etc.)

  • A six-sigma design and development background.

  • Has successfully launched medical device products from concept through launch.

  • Experience developing Class II and III medical devices.

  • Experience utilizing combination of analytical, statistical, computational, and empirical methods to gain deep understanding of design and minimize overall development timelines.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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Primary Work LocationUSA UT - Salt Lake City BAS

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Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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