Job Description Summary

One of BD's most profitable platforms Peripheral Intra-Venous Catheters (PIVC) with an annual revenue of $1B is looking for an energetic Project Lead who can help manage several projects to sustain, improve profitability, or ensure compliance to new standards and regulations for a large portfolio of products.

The successful candidate will be part of MDS PIVC PMO organization, reporting into the PIVC PMO Director. The position is located in BD's Technology Campus India site. The Project Lead will have to manage the multi-functional activities of the projects, lead the cross functional team (R&D, Supply Chain, Marketing, Quality, MA, Regulatory etc.), and own and execute the Design Change Plan.

• At least 3 years relevant experience in product development or design change is needed.
• Experience in planning work-streams, identifying risk and implementing action plans to optimize timelines and reduce execution risk.
• • Led the design control activities and implementation for their assigned project(s).
• Creation of the project work breakdown structures, risk management, and design change plans.
• Experience utilizing combination of analytical, statistical, computational, and empirical methods to gain deep understanding of design change impacts and minimize overall development timelines.

• Effectively manage several compliance or design change projects along with the PIVC R&D /cross functional teams.
• Collaborates with cross functional team to ensure timely delivery, review and approvals via regional registrations as well as other conflicting/dependent projects.
• Responsible for the execution, quality, and results of the project and the effectiveness of the resulting product change 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 project outcomes.
• Analyses design change situations and data with in-depth evaluation of multiple factors.
• Influences solutions to business or technical problems.
• Communicates and implements the scope and technical direction for the project team.
• Understanding of project management principles, theories & concepts.

• Technical / Professional Trainings: Project Management training
• Professional Certifications: Project Management Professional (PMP) (Preferred)
• ISO 13485, ISO 14971, DFSS, MDR, FDA Design Controls (21 CFR 820)

• Technical / Functional Skills:
  • Six-sigma design and development
  • Technical and project management skills and judgment to positively influence the direction of the project.
• Behavioral Skills
  • Looks for improvements in work processes by anticipating and dealing with problems and encouraging others to suggest innovations.
  • Interacts with Program Managers and functional Managers on technical and project matters often requiring coordination between teams.
• Soft Skills
  • Ability to clearly communicate project status to management and drive cross-functional alignment.

• Leadership Skills
  • Able to create and influence novel thinking of the team

• BS degree in Mechanical Engineering, Materials Science & Engineering, Biomedical Engineering or a closely related engineering degree is required.