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Principal Systems Engineer Risk

Req # JR - 023319 Location Bengaluru, Karnataka, India Additional Locations 56 Job Category Research and Development Date posted 07/30/2020

Are you looking for a career that matters?

We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives.

About Baxter

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis;sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacyautomation, software and services. The company’s global footprint and the critical nature of its products and servicesplay a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwideare building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcareinnovations that enable patient care.

Job Description - Principal Engineer, Risk Engineering

Apply a solid understanding of System Engineering practices and theories/practices in Risk Management toward the development of new or enhanced Software products or processes.  Support the advancement of Risk and Reliability competencies and execution across the Device SystemsSoftware Engineering organization.

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

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 teams in investigation of Risk and Reliability issues.


Minimum 10-12 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 for Software development.

Must possess engineering knowledge and software product development experiencein Medical Devices /Aerospace domain.

Experienced in at least of one of the following programming languages: C, C++, C#, Java

Experience with different operating systems – Linux and database query language

Working knowledge of Medical Device regulations (21CFR820, European MDD, Canadian Medical Device regulations, etc.).

Hands on experience in developing software design/architecture complying to standards such as ISO 13485, IEC 62304.

Understanding and application of such as ISO 14971, IEC 61025, IEC 62366, IEC 60601 is an added advantage.

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.

B.E/B. Tech in Computer Science / Electronics & Communication / Electrical or related field and 10 to 12 years related experience.

A Career That Matters

Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific

innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and

technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing

creative collaborations that bring our mission to life for patients every day.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion,

gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other

legally protected characteristic. 

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to and let us know the nature of your request along with your contact information.

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