- 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
• 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.
Candidate has to work on Medical Devices