Job Description Summary
Job Description
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. The company develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD has 70,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
About BD TCI
BD, a 125-year-old global medical device company has started its Research and Development Organization in Bangalore India which is BD Technology Campus India (TCI). This R&D center will be an integral part of the global R&D, in design related activities and full product life cycle management. This R&D organization will have highly skilled associates in the field of engineering and science.
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Position Summary
One of BD's most profitable platforms Advanced Access Devices (AAD) with an annual revenue of nearly $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 AAD PMO organization, reporting into the AAD 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.
Educational Background
BS degree in Mechanical Engineering, Materials Science & Engineering, Biomedical Engineering or a closely related engineering degree is required.
Professional Experience
- At least 7 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.
- Lead 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.
Job Responsibilities
- Provide the day-to-day job responsibilities for which the associate is responsible for the applicable position.
- Effectively manage several compliance or design change projects along with the AAD R&D/cross functional teams
- Collaborate 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
- Challenge core team members, functional leaders and business leaders regarding functional and cross functional strategies and approaches in order to improve project outcomes
- Analyze design change situations and data with in-depth evaluation of multiple factors.
- Influence solutions to business or technical problems
- Communicate and implement the scope and technical direction for the project team.
- Understanding of project management principles, theories & concepts.
Knowledge and Skills
Knowledge
- 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)
- Has a thorough understanding of the design change process and the design control activities required to be compliant to BD and global regulations.
Skills
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.
Required Skills
Optional Skills
.
Primary Work Location
IND Bengaluru - Technology Campus
Additional Locations
Work Shift