Staff Engineer - Systems Engineering

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 Staff Engineer – Systems, you will lead and manage risk management activities for Acute care diagnostic products, specifically Blood gas analyzer systems. You will play a critical role in ensuring the safety and compliance of both new and existing products through thorough risk assessment and mitigation strategies. This position requires a strong background in risk management, a deep understanding of IVD regulations, and exceptional skills in stakeholder management and cross-functional collaboration. You will also provide mentorship to junior team members, fostering a culture of continuous improvement and professional growth.

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:

• Develop and implement comprehensive risk management strategies for Acute care diagnostic devices eg Blood gas analyzer, ensuring compliance with relevant standards and regulatory requirement.
• Lead risk management activities including risk assessment, risk analysis, and risk control strategies.
• Conduct ongoing risk assessments for products in the field, Review and update risk management documentation and risk mitigation as needed.
• Interface with internal and external stakeholders to provide updates on risk management activities and address any risk-related concerns.
• Partner with R&D, quality assurance, regulatory affairs, and clinical teams to ensure a cohesive approach to risk management.
• Facilitate risk management discussions and decision-making across cross-functional teams.
• Ensure all risk management activities comply with relevant regulations and standards, including ISO 14971 and FDA guidelines.
• Stay current with industry trends, emerging risks, and regulatory changes to ensure proactive risk management

The essential requirements of the job include:

• Bachelor’s degree in engineering, Biomedical Science, Risk Management, or a related field with 10-12 years of experience in systems engineering, with a focus on medical devices or diagnostic systems risk management.
• Experience in Medical Device industry standards and regulations (EU IVDR, MDR etc.)
• Deep understanding of risk management principles and regulatory requirements, including ISO 14971, FDA guidelines, and other relevant standards
• Strong analytical and problem-solving skills, effectively evaluates information / data to make decisions, anticipates obstacles and develop plan to resolve.
• Expert level skills in collaborating with different stakeholders, influencing decisions and an ability to take strategic view.
• Demonstrated execution of meeting project goals while satisfying quality, safety, and compliance
• Experience in systems engineering tools (e.g., Application Lifecycle Management tools – DOORS, Polarion etc.
• Demonstrated ability to mentor and guide junior team members effectively.

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.