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In our line of work, life isn’t a given - it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we’re located. Creating impactful innovations like ours, doesn’t happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career .

Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.

As a Systems Engineer specializing in Requirements and Risk Management for Immunoassay Analyzer Devices, you will play a crucial role in ensuring the successful development and deployment of cutting-edge medical diagnostic technologies. This role will involve meticulous attention to detail, a comprehensive understanding of systems engineering principles, and a focus on cybersecurity and vigilance to ensure compliance with regulatory standards.

This position is part of the Radiometer R&D located in Bengaluru and will be hybrid. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

You will be a part of the Product systems engineering team and report to the Engineering Manager responsible for Systems definition and design function. If you thrive in a multifunctional, leadership role and want to work to build a world-class Systems engineering organization—read on.

In this role, you will have the opportunity to:

• Work closely with product managers and system architects to ensure alignment between customer expectations and technical requirements.

• Provide systems engineering expertise and support to cross-functional teams throughout the product development lifecycle.

• Conduct requirements reviews and manage changes throughout the development lifecycle.

• Develop risk management plans and implement risk mitigation strategies to minimize potential hazards and ensure patient safety. Monitor and track identified risks throughout the project lifecycle, implementing corrective actions as necessary.

• Collaborate with cybersecurity experts to assess and address cybersecurity risks associated with Immunoassay and Blood gas Analyzer Devices.

• Establish and maintain vigilance systems to monitor the performance, safety, and effectiveness of Immunoassay and Blood gas Analyzer Devices in the field

  The essential requirements of the job include:

• Bachelor’s or master’s degree in engineering or a related field with minimum of 4 years of experience in systems engineering, with a focus on medical devices or diagnostic systems.

• Proficiency in requirements management tools and methodologies, such as DOORS, Polarion, or similar.

• Experience in conducting risk assessments and applying risk management techniques in accordance with ISO 14971 and other relevant standards.

• Familiarity with regulatory requirements and standards for medical devices, including FDA regulations (e.g., 21 CFR Part 820), IEC 62304, IEC 62366, and cybersecurity standards (e.g., IEC 80001, ISO 27001).

• Excellent communication and collaboration skills, with the ability to work effectively in cross-functional teams and communicate technical concepts to non-technical stakeholders.

• Strong attention to detail, analytical thinking, and problem-solving skills.

  It would be a plus if you also possess previous experience in :

• Knowledge of IVD device development processes and QMS requirements

• Certification in Systems Engineering (e.g., INCOSE CSEP) or related field

At Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.