Baxter Medical Devices
Location
Bangalore | India
Job description
Vantive: A New Company Built On Our Legacy
Baxter is on a journey to spin off our $5B Kidney Care segment into a standalone company. Vantive. will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.
At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us are driven to help improve patients' lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
.Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.
The Renal Center of Excellence (CoE) Compliance & Reliability Engineering teams is a part of the R&D organization that supports the Renal Care business unit. Within the team we provide compliance and reliability engineering activities in all product phases, innovation initiatives, new product development and improvement programs for existing therapy systems. This collaborative role gives you the direct opportunity to define solutions to new products and services to patients and continue Baxter's mission to save and sustain lives.
Baxter is a global company with R&D sites at multiple locations in the world competences and capabilities are spread over the different R&D sites, and you will commonly collaborate with colleagues across several of these R&D sites. Work assignments within the team are highly variable and we can promise you a work environment with exciting project management challenges and variability in your day-to-day activities.
The Sr. Manager role is responsible for leading the Compliance and Reliability Engineering teams and supporting the projects within the Kidney Care portfolio.
Essential Duties and Responsibilities:
Manage team of compliance and reliability engineers supporting research and development (R&D) work for medical devices and regulated healthcare products
Ensure Compliance organization manages product safety and wireless compliance activities for assigned programs, working with cross-functional product development partners to identify requirements, develop and execute compliance plans, coordinate testing activities, review compliance testing results and partner with certification agencies to certify products.
In partnership with Baxter's Environmental Health and Safety team, support efforts to comply with environmental regulations (e.g. RoHS, REACH, WEEE).
Keep abreast of changes to product standards, wireless standards and regulations affecting medical and wireless products.
Serve in a consultative capacity on product safety & regulatory compliance and product qualification activities to ensure compliance with national and international product safety regulatory requirements in the company's product designs.
Facilitate and provide guidance to design teams in reliability process execution using relevant methodologies, tools and techniques
Interact through program updates and reviews with all functions and levels of management ensuring effective ongoing communications across teams and stakeholders.
Drive compliance and reliability engineering strategies and training across the organization
Qualifications:
Functional management experience with a team of experienced R&D engineers such as Mechanical, Electrical, Systems, Compliance, Reliability etc.
Deep understanding of medical device development and adherence to FDA, ISO and IEC design control procedures, regulations, and standards.
Experience in design and development of complex medical device through all product life cycle phases
Ability to manage cross-functional global teams simultaneously in a matrix environment.
Ability to provide technical leadership for medical device projects with substantial complexity and scope.
Experience in resolving complex technical problems using strong analytical skills.
Demonstrate experience in driving organizational change for continuous improvement.
Experience interacting with regulatory and certification agencies for submissions and audits.
Be a clear thinker and decisive in communication and actions with leadership, stakeholders and within the team
Education and Work Experience:
BS or MS in engineering or similar field
10+years of experience in engineering 5+ years functional management experience
Demonstrated experience working with certification bodies (UL, TUV, Intertek CSA etc.)
Experience interacting with regulatory and certification agencies for submissions and audits
Reasonable Accommodations
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