Senior Systems Engineer

1 month ago

Bangalore, India Danaher Corporation Full time

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 Senior Engineer - Systems, you will be responsible for managing and mitigating risks associated with Acute care diagnostic products. Your primary focus will be on vigilance and post-market surveillance to identify, assess, and address potential risks and safety issues. You will work closely with various teams within the company to ensure that all risk-related concerns are effectively managed and resolved.

This position is part of the Radiometer R&D located in Bangalore, India and will be On-site. 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 Systems Engineering Manager, R&D responsible for Systems definition and design function for Acute care diagnostics. 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:

  • Lead post-market surveillance activities to continuously monitor the safety and effectiveness of medical diagnostic devices.

  • Oversee vigilance processes, including investigating and reporting adverse events, product complaints, and safety concerns to regulatory bodies and internal stakeholders.

  • Analyze post-market data to identify trends, potential risks, and areas for improvement.

  • Implement and manage corrective and preventive actions (CAPA) to address identified risks and safety issues.

  • Collaborate with R&D, quality assurance, clinical, and regulatory teams to address risk-related concerns and ensure cohesive risk management practices.

  • Ensure thorough documentation of all risk management activities, including post-market surveillance reports, vigilance reports, and risk assessment records

The essential requirements of the job include:

  • Bachelor’s degree in engineering, Biomedical Science, Risk Management, or a related field with 5-7 years of experience in systems engineering, with a focus on medical devices or diagnostic systems post-market surveillance and Vigilance.

  • In-depth knowledge of risk management standards (e.g., ISO 14971), regulatory requirements (FDA, EU MDR), and industry best practices

  • Proven ability to analyze field data, conduct risk assessments, and develop effective risk mitigation strategies.

  • Excellent communication skills with the ability to present complex information clearly and effectively.

  • Detail-oriented with strong analytical and problem-solving abilities

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

  • Formal Systems Engineering qualifications (e.g., INCOSE CSEP, ISO 15288) or working towards.

  • Advanced understanding of EU IVDR, ISO 13485, ISO 14971, ISO 62366 is a big plus

  • Experience in complex electronic and/or software systems

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.

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