Sr Eng, Systems

4 days ago

bangalore, India Baxter Full time

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate 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.

Job Description

As a System engineer, responsible for end to end development of the product, from capturing the user/marketing needs to final product release. Interact with customers and marketing to develop and refine user requirements. System engineer plays a critical role in product development, making sure the product meets all the functional and performance requirement. He/She is responsible to make sure the manufacturing and service requirements are translated into product design. Lead the development and documentation of the product systems architecture and systems level design, including the decomposition of the system architecture and requirements into subsystem and interface specifications. Develop the Risk Management Plan and execute the Risk Management activities defined by the plan. Develop and delivers the reliability goals of the product. Develop and deliver the regulatory compliance requirement in product design for intend country of use. Resolve competing constraints between interrelated functions (engineering, manufacturing, regulatory, marketing, etc.) required to deliver the product to market. Plan and execute system integration activities to minimize issues in systems verification and validation. Develop test plans, test protocols, and test reports for product integration testing. Document traceability from requirements to verification activities, and from requirements to design entities. Resolve systems-related technical issues by applying problem solving tools such as cause and effect diagrams, Pareto charts, etc. Adheres to Baxter Quality Management system & supports the quality audits.

 Qualifications

• Demonstrated facilitation and negotiation skills in driving closure on product/program-related decisions/issues

• In depth knowledge of the regulatory environment for Design, Develop and Manufacture of Medical products.

• Demonstrated strong analytical and problem solving skills

• Excellent verbal and written communication skills

• Success in working with multifunctional, global teams.

• Excellent interpersonal/communication/influencing skills required

• Bachelors/Master’s Degree in Computer Science, Mechanical, Electrical, Biomedical Engineering or equivalent

• Minimum of 10+ years’ experience in product development or related field, in the pharmaceutical and medical products industry.

• Familiarity with ISO, FDA and other regulatory standards

• Demonstrated experience working with vendors with different models of engagement.

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