Sr Engineer, Systems, Baxter

Sr Engineer, Systems

Baxter

Location:

India, Bengaluru

Category:

Research and Development

Contract Type:

Not provided

Salary:

Not provided

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Job Description:

Apply a solid understanding of System engineering practices and theories/practices in Risk Management toward the development of new or enhanced products or processes. Support the advancement of Risk and Reliability competencies and execution across the Device Systems Engineering organization. At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Job Responsibility:

Plan, schedule, and lead project assignments using appropriate engineering techniques, processes, and methods with minimal guidance
Identify and define high level requirements for a product or a feature that enhance the quality of therapy
Develop System requirements
propose architectures and connectivity specifications of medical devices with each other and with external medical systems
Ensure appropriate traceability between requirements, interface specifications, design and verification deliverables
Identify and define risk and reliability related requirements from applicable product standards (collateral and particular)
Provide leadership and coaching to design teams in Risk process execution using relevant methodologies, tools, and techniques
Lead and coach design teams in the development/maintenance of Risk planning and deliverables aligned with Baxter Global Risk Management procedures
Collaborate with cross-functional resources (e.g. hardware, clinical, human factors, etc.) involved in Risk Management and Reliability process activities
Support sustaining teams in investigation of Risk and Reliability issues
Lead teams through credibility and influence

Requirements:

B.S.in Mechanical Engineering, Electrical Engineering with minimum 6-12 years of hands-on experience in Product Design and development, and fluent in full life-cycle product development methods/activities, preferably in a regulated industry
Must possess engineering knowledge and product development experience in relevant electromechanical disciplines, preferably Medical Devices
Working knowledge of Medical Device regulations (21CFR820, European MDD, Canadian Medical Device regulations, etc.)
Solid understanding and application of the standards related to Risk Management: (e.g., ISO 14971, IEC 61025, IEC 62366, IEC 60601, ISO 13485 etc.)
Demonstrated experience in creation of typical failure analysis deliverables at different levels of product (Hazards Analysis, FMEAs, FTAs, etc.)
Experienced in handling customer complaints, performed the root-cause analysis in investigations and resolve them as part of engineering team
Expertise and fluency in Excel, Minitab, Doors, and other Requirements Management &
Risk tools
Strong critical thinking skills
Requires strong organization and polished communication skills (both written and oral), with the ability to interface with both technical and non-technical personnel throughout the organization
Able to work independently or with a cross-functional team in a fast-paced environment
Able to lead multiple projects and work across organization boundaries

What we offer:

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Additional Information:

Job Posted:

March 20, 2025

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