Senior Risk Engineer (NPI, Medical Devices)

Job Title

Job Description

Senior Risk Engineer (NPI, Medical Devices)

In late January, we announced that Bridgefield Capital signed an agreement to acquire Philips’ Emergency Care business which includes leading brands and products like HeartStart AEDs, Intrepid and DFM100 monitor defibrillators, Tempus monitor and Tempus ALS systems, and Corsium and ECI informatics solutions. We expect the transaction to close at the end of 2025.

With Bridgefield’s support and building on our 40+ year legacy of growth and innovation in emergency medical technology, the Emergency Care business will continue passionately pursuing our mission of saving lives, lowering the cost of healthcare, and advancing the science of resuscitation while serving the public access AED, EMS, military, and hospital market segments. 

In this role and as part of an agile company that has the dedicated resources needed to achieve its strategic goals, you’ll have every opportunity to become a part of the “NewCo” we are forming and grow both personally and professionally and potentially make an even bigger impact on the acute care space – as well as on the consumers, patients and healthcare workers who depend on these innovative life-saving solutions.

Your role will be part of the systems team for Medical Device NPI and will cover:

• Creating and/or approving all risk management deliverables for one complex or multiple simple products throughout its' lifecycle.

• Providing business-level guidance on product hazards and harms and collaborating with medical affairs to ensure identification of harms and alignment with applicable regulations and standards, aiming to mitigate risks and safeguard patient, user and consumer safety.

• Participation in process improvement initiatives to enhance efficiency and effectiveness in risk management, striving for best-in-class practices by identifying and implementing enhancements that streamline processes and improve overall performance in managing and mitigating risks.

• Monitoring key performance indicators (KPIs) pertaining to product risk processes, assisting senior risk managers in facilitating informed decision-making and strategic planning within the department to ensure optimal performance and compliance with regulatory standards.

• Implementation of effective risk assessment methodologies to comprehensively evaluate potential hazards associated with products, facilitating informed decision-making and proactive mitigation strategies.

• Coordinates with User Interface, Engineering, Marketing, Procurement, Operations, and V&V teams, and with the post market surveillance team for assessing of field risks and their remediation.

• From competitive salary and performance bonus to family friendly policies, flexible benefits and access to Philips University, a career at Philips comes with all sorts of wonderful benefits.  Be sure to speak to your recruiter about all the benefits on offer.

How we work together

• We believe that we are better together than apart. For this office-based role, this means working in-person at least 3 days per week in our Farnborough office

You’re right for this role if:

• You Bachelor's/Master's Degree in Medical Sciences, Engineering, Life or Physical Science, Computer Science/Software/Electronics development or equivalent.

• You have experience leading risk management ideally in a medical device development environment, but other regulated industries will be considered (Pharma, Defense, Automotive, Aerospace)

• You have worked in product development within an ISO 14971 risk management process (preferably including experience of product approvals for EU-MDD, EU-MDR and FDA).

• You have a flexible attitude, with a willingness to accept and drive change, work within a dynamic environment

• You are a clear and concise communicator, with the ability to present to a broad range of stakeholders

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here .

Because we are at our best when you are, you can safely share any reasonable tools or adjustments needed during our recruitment process and beyond.

For more information, read our Inclusion and Diversity Policy and, to know more about your Human Rights, we encourage you to view this report.

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