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Principal Eng, Risk Management

Req #: JR - 041078 Location Bengaluru, Karnataka, India Job Category: Research and Development Date Posted: 06/10/2021

Overview

This is where new knowledge is discovered. Baxter’s Research and Development teams work cross functionally to innovate, develop and introduce creative solutions for patients needs globally. From Scientists to Engineers, your work creates the products that save and sustain lives.

  • Support for Parents

  • Continuing Education/
    Professional Development

  • Employee Health &
    Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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Success Profile

What makes a successful Research and Development team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Courage
  • Action Oriented
  • Collaborates
  • Cultivates Innovation
  • Manages Ambiguity
  • Drives Results

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Principal Eng, Risk Management

This is where you save and sustain lives

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.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

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 pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

Job Summary

Job Title – Principal Eng, Systems

Location – Whitefield, Bangalore

Shift – General

Primary Function / Primary Goals / Objectives:

This position owns & performs the Risk management activities for a family of dialysis devices as they are used in dialysis therapy, in accordance with the regulatory standards (main being ISO 14971) & requirements.

Job Responsibilities

  • Responsible for performing the activities associated with the Risk Management of one or more products in various stages of the product lifecycle from new product development to post market surveillance.
  • Performs risk assessment on an ongoing basis for any proposed design/material/process change or an observation in the field/service or manufacturing to determine the impact and need for any mitigation.
  • Come-up with the recommended mitigation with the rationale.
  • Ensure that no unacceptable risk goes undetected and unmitigated.
  • Expedite, manage, and coordinate interrelated Risk Management 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 Risk Management.
  • Facilitate an improved understanding of the interrelationship between Risk and Reliability.
  • Working knowledge of FMEAs and standards applicable to Reliability Engineering.
  • Provides subject matter expertise to product development teams to ensure Risk Management principles are applied throughout the development cycle.
  • Leads Risk Management activities in coordination with other cross-functions like HW, SW, HF,…
  • Collaborates with Engineering, Manufacturing and Service organizations in the development of design FMEA, Process FMEAs and roll-up into Risk Management files.
  • Creates and approves Design History File deliverables associated with Risk Management.
  • Provides ongoing risk analysis and identification of required risk mitigations to ensure safe, effective product.
  • Able to analyze risk/tradeoffs and make recommendations of appropriate path forward.
  • Successfully influences stakeholders and cross-functional team members within the project.

Qualifications

  • Graduate degree in Engineering, with approximately 10 years of practical Electromechanical Medical Device Design experience, some of which is in risk management.
  • Able to effectively manage and lead complex projects. Has led the Risk Management activities of at least one significant project.
  • Sound knowledge of Risk management standard ISO 14971 and its application.
  • Good understanding of medical device QMS ISO 13485 with experience of having worked in this environment.
  • Must have good working knowledge of regulations and standards affecting medical devices and have experience with products under design controls, documentation controls, risk management, and validation.
  • Demonstrated experience in creation of typical failure analysis deliverables (Hazards Analysis, FMEAs, FTAs, etc.)
  • Requires a high level of independence and excellent interpersonal and communication skills.
  • Able to prepare and make written and verbal presentations to cross-functional audiences as required.
  • Team player
  • Six Sigma Green belt or Black Belt (DFSS) certification preferred.

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 [email protected] and let us know the nature of your request along with your contact information.

041078

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Reagan, Senior Research Scientist in the United States

"For me, the best thing about working at Baxter is being able to do work that’s important to people—especially patients—outside of Baxter's walls. Inside our walls, I get to work with a fantastic team, and we know we're making a difference."

Reagan

Meet Karthik, Director of Renal Care R&D - Digital Health & Co-President of the Asian Leadership Network Business Resource Group, United States

"I’m excited about my role because I believe that digital initiatives can make a tremendous impact on lives by allowing people to access the same therapies and have similar care — whether in a hospital, a healthcare clinic, or the patient’s home — anywhere in the world."

Karthik

Meet Amitha, Research Associate in India

"Coming from a non-healthcare academic background, my current role has offered ample opportunities to learn a lot of new things. Leaders at Baxter are motivating, help us grow and provide a collaborative environment. The role gives me opportunities to have technical discussions with peers and subject matter experts globally, to learn interacting with customers, and manage project deadlines and deliverables. I am excited about shaping my career here at Baxter."

Amitha

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Reagan

Meet Reagan, Senior Research Scientist in the United States

"For me, the best thing about working at Baxter is being able to do work that’s important to people—especially patients—outside of Baxter's walls. Inside our walls, I get to work with a fantastic team, and we know we're making a difference."

Karthik

Meet Karthik, Director of Renal Care R&D - Digital Health & Co-President of the Asian Leadership Network Business Resource Group, United States

"I’m excited about my role because I believe that digital initiatives can make a tremendous impact on lives by allowing people to access the same therapies and have similar care — whether in a hospital, a healthcare clinic, or the patient’s home — anywhere in the world."

Amitha

Meet Amitha, Research Associate in India

"Coming from a non-healthcare academic background, my current role has offered ample opportunities to learn a lot of new things. Leaders at Baxter are motivating, help us grow and provide a collaborative environment. The role gives me opportunities to have technical discussions with peers and subject matter experts globally, to learn interacting with customers, and manage project deadlines and deliverables. I am excited about shaping my career here at Baxter."

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