Senior Principal Engineer, Systems Specialist

3 days ago

Bengaluru, Karnataka, India Baxter Full time

Visionary Leadership in Medical Device Development

Baxter is revolutionizing the kidney care space with the launch of Vantive, a new company built on our legacy. As a Senior Principal Engineer, Systems Specialist, you will play a crucial role in shaping the future of medical device development.

About Baxter

Baxter provides a comprehensive portfolio of essential renal and hospital products, including home, acute, and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software, and services. Our global footprint and critical products and services expand access to healthcare in emerging and developed countries.

Role Summary:

As a Senior Principal Engineer, Systems Specialist, you will be responsible for product requirements management, traceability, design history file structure and maintenance, product risk management, system integration, verification, and validation of medical devices. This position may own and perform relevant system engineering activities for a family of devices in acute therapies.

Key Responsibilities:

  • Perform system engineering activities for one or more products in various stages of the product lifecycle from new product development to post-market surveillance.
  • Gather inputs for requirements from various sources, including standards, user needs, regulatory, quality, human factors, manufacturing, and service.
  • Expedite, manage, and coordinate interrelated systems activities across functions, within the constraints of human and financial resources and changing priorities.
  • Participate in identifying and planning tasks, activities, and resourcing needs related to systems engineering.
  • Facilitate an improved understanding of the interrelationship between requirements, risk, and reliability.
  • Work with a working knowledge of FMEAs and standards applicable to systems engineering.
  • Create design concepts and research methodologies that best meet current and future customer and business needs for a product or process domain area.
  • Understand clinical and user needs and apply them to product realization. Create and maintain design history file elements.
  • Successfully influence stakeholders and cross-functional team members within the project.
  • Apply life cycle management principles across all phases of life cycle management.
  • Teach and mentor others in life cycle management methodologies.
  • Initiate, develop, and lead technical feasibility analysis for products or subsystems; translate customer/user needs to product needs.
  • Propose and drive solutions to complex technical problems that are ambiguous and diverse in scope.
  • Drive adherence to FDA, ISO, and IEC design control procedures, regulations, and standards.
  • Anticipate technical challenges and risk scenarios and prepare, lead, and execute mitigation strategies to ensure optimal results.

Qualifications and Requirements:

  • An engineering graduate in electrical, mechanical, biomedical, or related engineering discipline with 12-18 years of experience. Prior experience in medical/acute device domain is a plus.
  • Demonstrated ability to work with technical leadership teams to implement product platform/subsystem multi-generation technology plans for a specific release of a global program/product.
  • Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (electrical, mechanical, software, etc).
  • A demonstrated track record in electromechanical system development, preferably medical devices or other highly regulated products such as military hardware.
  • Effective communication skills, both verbal and written.
  • Demonstrated strategic technical planner and thinker with the ability to drive architecture/platform/technology deliverables into the product roadmap to ensure competitive differentiation.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy, which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

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