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Sr. Principal Compliance Engineer (Hybrid)

Req # JR - 150624 Location Bengaluru, Karnataka, India Job Category Research and Development Date posted 10/15/2024
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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 Heath & Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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

Sr. Principal Compliance Engineer (Hybrid)

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Vantive: A New Company Built on Our Legacy

Since last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed sale of Vantive to funds managed by the Carlyle Group is subject to receipt of customary regulatory approvals and satisfaction of other closing conditions.

The Renal Center of Excellence (CoE) Compliance Engineering team is a part of the R&D organization that supports the Renal Care business unit. Within the team we provide compliance engineering activities in all product phases, innovation initiatives, new product development and improvement programs for existing therapy systems. This collaborative role gives you the direct opportunity to define solutions to new products and services to patients and continue Baxter’s mission to save and sustain lives.


Baxter is a global company with R&D sites at multiple locations in the world; competences and capabilities are spread over the different R&D sites, and you will commonly collaborate with colleagues across several of these R&D sites. Work assignments within the team are highly variable and we can promise you a work environment with exciting project management challenges and variability in your day-to-day activities.

In this role, the Sr. Principal Compliance Engineer will be responsible for leading the efforts in the coordination and management of standards compliance activities for assigned programs. This includes working with cross-functional product development partners to identify requirements, develop and execute compliance plans, coordinate testing activities, review compliance testing results and partner with certification agencies to certify products. This position requires candidates to maintain their knowledge of current standards and developing or changing standards that affect Kidney Care products.

Essential Duties and Responsibilities:

  • Coordination and management of product safety and wireless compliance activities for assigned programs, working with cross-functional product development partners to identify requirements, develop and execute compliance plans, coordinate testing activities, review compliance testing results and partner with certification agencies to certify products.

  • Partner with design engineers to develop product requirements to comply with standards and regulations for intended use markets, develop Compliance Plans, participate in design and development activities and partner to resolve product certification, wireless and product safety issues.

  • Develop and drive product certification strategy to facilitate market access in the intended market(s) and lead compliance issues throughout the lifecycle of the product.

  • In partnership with Baxter’s Environmental Health and Safety team, support efforts to comply with environmental regulations (e.g. RoHS, REACH, WEEE).

  • Facilitate and coordinate input from multiple cross-functional partners including Regulatory team, program management, R&D teams, manufacturing sites and service locations to develop and drive comprehensive product certification and compliance strategies, develop and maintain therapy area compliance roadmaps and dashboards.

  • Keep abreast of changes to product standards, wireless standards and regulations affecting medical and wireless products.

  • Ensure that all in-house compliance test equipment complies with the test requirements specified in compliance standards and regulations.

  • Schedule compliance testing for products at onsite test facility and at external test laboratories.

  • Manage and plan wireless host testing on products that have implemented wireless technologies.

  • Support regulatory submissions and wireless approvals (e.g. EU, UL, Canada, Korea, Japan, Australia/New Zealand).

  • Prepare standards test reports and other documentation in accordance with applicable regulations.

  • Serve in a consultative capacity on product safety & regulatory compliance and product qualification activities to ensure compliance with national and international product safety regulatory requirements in the company’s product designs.

  • Provide technical direction and communication across engineering, contracts, and legal to ensure understanding, cooperation and coordination.

Qualifications:

  • Knowledge of worldwide medical device requirements. Deep understanding of the US, European Union, Canadian, Australian, Japan, Brazil and China markets.

  • Experience with IEC 60601-1 family of standards and wireless regulations preferred.

  • Excellent understanding of EMC and wireless test equipment and testing method in accordance with domestic and international standards.

  • Knowledge of EMC and wireless regulations and certification procedures applicable to Medical Devices sold worldwide including testing documentation, certification requirements and procedures (i.e.IEC60601-1-2, CISPR 11, FCC, RED etc.).

  • Ability to perform diagnostics and correct EMC failures in conjunction with design engineers.

  • Strong electronics background is preferred.

  • Experience in Requirements Management, Configuration Management, Defect Tracking and Traceability Experience with EMC design tools, automated EMC testing tools, electronic test equipment (oscilloscopes, logic analyzers).

  • National/international product safety standards knowledge required

  • Excellent written, oral and interpersonal skills

  • Must be proficient at time management and multitasking

  • Knowledge of FDA's guidance on design controls and software validation (IEC 62304), as well as ANSI/IEEE standards for EMC and wireless engineering

  • Demonstrated experience interfacing with regulatory agencies, conformity assessment bodies (UL, Intertek, TuV,CSA, etc.) and standards development organizations (IEC, ISO, NEMA, NFPA, ETSI, etc.).

  • Demonstrated strong analytical and problem-solving skills

  • Success in working with multifunctional, global teams.

  • Strong team player, able to meet deadlines and handle changing priorities

  • Experience in resolving complex technical problems using strong analytical skills

  • Success in delivering results on technical challenges including investigative and problem-solving skills

Education and Work Experience:

  • BS or MS in engineering

  • 15 +years of experience in compliance engineering

  • Demonstrated experience working with certification bodies (UL, TUV, Intertek CSA etc.)

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.

Reasonable Accommodations

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

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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Karnataka- 560 048
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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.”

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.”

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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