Job Description

  • Senior LSD will lead a team of engineers in the development of new and exciting product for Renal business.
  • As a LSD, 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.
  • LSD plays a pivotal 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.
  • Develop and maintain an effective and corroborative working relationship with external development partners.
  • 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- 15 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.

Job Location: Bangalore
Experience (Years): 10 – 18 Years

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