Job Description Summary
Over the last decade, BD has established a strong footprint in India for supporting R&D, Quality and Operations. BDx started a partnership in 2011 with a third-party environment for delivering sustaining engineering for R&D. Since 2016 this partnership with the third-party environment has expanded significantly across R&D, Quality and Regulatory. Currently there are 1500+ associates with the third-party engagement, delivering sustaining engineering/new product development support for R&D, post market surveillance for Quality, and MDR/IVDR activities for regulatory.
BD is currently seeking an experience leader from the engineering and R&D function with a strong background in managing third party vendors to lead the strategic partnership with the third-party environment to ensure the current services are maintained, implement continuous improvement programs to improve efficiency, reduce cost and deliver first time right. In addition, this role will require to think strategically by working with the different functions and business units to understand the needs and come up with creative solutions to further simplify the operations across different functions. This Director serves as the leader for the India Development Center (IDC) located at HCL in Chennai, India.
This role will embed with the IDC team and be responsible for working with the local leadership across the third party organization in R&D, Quality, Regulatory on the ground to run the day to day operations. Further this role will engage with the business unit’s stakeholders across the regions to understand the current delivery of services, and identify the gaps with respect to oversight effort, first time right, timeliness and project management effectiveness on the deliverables and implement action on the ground with the team. This role will continue to develop and grow the impact that the IDC has for BD. This role will identify with the business the various opportunities and prioritize all aspects of value capture opportunities with direct impact on revenue growth and product cost reductions. This role will ensure product engineering rigor, technical excellence and full compliance across the BDX portfolio of Platforms and drive process improvements in the functions supported and in partnership with the IDC. This role will be based in Chennai, India and report to VP, Enterprise Operations.
- Lead a global offshore center for supporting sustaining engineering, NPD and life cycle management activities across the functions R&D, Quality, Regulatory, and operations
- Lead the organization to track all activities across BDx monitor the performance metrics and implement appropriate action plans on the ground by working with the team in the offshore center leadership team
- Understand the expectations for each project, and business unit and work with the third party partner ensure appropriate experienced candidates are deployed for the assignment
- Identify critical roles in the offshore center and work with the partner to develop appropriate succession planning for the critical roles
- Develop, maintain the critical training needs for the job and drive the implementation of different training programs with the partner organization
- Provide technical leadership on key projects and mentor the leads and associates on an ongoing basis and track the progress
- Govern the SOW process to ensure appropriate rate cards and qualifications are reflected for the type of role needed from BD with the qualifications of candidates
- Maintain the finance tracker on a monthly basis to track the spend by each SOW, by business unit and ensure compliance to filing the invoices on time
- Identify opportunities to improve efficiency and drive implementation of automation to show improvements on the ground on an yearly basis on the activities that are repetitive
- Monitor with the local leadership closely on the Infosec requirements of BD and ensure full compliance by all the associates
- Ensure compliance to c2c on all common procedures across BDx and business specific procedures
- Identify new technologies and solutions offered by the strategic partner and bring it to forefront with BD stakeholders and identify new opportunities
- Maintain the governance model in place and ensure appropriate adherence to the policies established by the governance committee.
Experience and Education:
- Must have at least 20+ years’ experience in managing a large engineering function in a medical industry and with a strong background in single use disposables and electromechanical devices.
- Must have a demonstrated experience in running life cycle management projects across and a proven capability in applying engineering first principles to advance various programs
- Must have leadership capability to manage a large external strategic partner
- Must have experience in managing third party vendors on a day to day basis on the entire operations from forecast, budget, metrics, KPI’s, efficiency improvements, and overall governance
- Must have a Masters Degree in Engineering and preferably with an MBA
Knowledge and Skills
- Strong knowledge and experience in managing large life cycle management programs across Class II, and III medical devices
- Strong knowledge and hands on experience in lean methodologies and process excellence with six sigma capabilities
- Broad and deep understanding of disciplined product development processes, regulatory, and quality requirements
- Experience in managing major strategic transformation initiatives and a strong track record of achieving business goals while delivering results on time and on budget
- Strong ability to address and resolve complex problems, effectively prioritize competing objectives, negotiate, and manage conflict
- Drive the change management for digital transformation across the center from identification, optimization, and implementation in product
- Accountable for budget, cost management, scheduling, governance, and performance of the center
- Strong organizational leadership skills, interpersonal, influence, and conflict management skills
- Strong technical and managerial judgment, strong communication skills
- Demonstrated ability to communicate ideas and knowledge effectively and clearly to teams
- Strong skills in project planning, management, and budgeting with an orientation towards building and leading effective teams
- Experience with ISO requirements and GMP guidelines, FDA regulations, medical device design control, and manufacturing scale up processes
Primary Work Location
IND Bangalore - Technology Campus