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 healthcare costs, and advancing resuscitation science while serving public access AED, EMS, military, and hospital markets.
This role offers an opportunity to be part of the systems team for Medical Device NPI, focusing on:
* Creating and approving risk management deliverables for complex or multiple simple products throughout their lifecycle.
* Providing guidance on product hazards and harms, collaborating with medical affairs to identify harms, and ensuring compliance with regulations and standards to mitigate risks and ensure safety.
* Participating in process improvement initiatives to enhance risk management efficiency and effectiveness.
* Monitoring KPIs related to product risk processes to support informed decision-making and strategic planning.
* Applying risk assessment methodologies to evaluate potential hazards and develop mitigation strategies.
* Coordinating with UI, Engineering, Marketing, Procurement, Operations, V&V, and post-market surveillance teams for field risk assessment and remediation.
We offer competitive salary, performance bonuses, family-friendly policies, flexible benefits, and access to Philips University. Discuss all benefits with your recruiter.
Working style: We believe in working together effectively, which for this role means working in-person at least 3 days/week at our Farnborough office.
Ideal candidates will have:
* Bachelor's/Master's in Medical Sciences, Engineering, Life or Physical Sciences, Computer Science, Electronics, or related fields.
* Experience leading risk management in medical device development or regulated industries (Pharma, Defense, Automotive, Aerospace).
* Experience with ISO 14971 risk management process and product approvals (EU-MDD, EU-MDR, FDA).
* A flexible attitude to adapt and drive change in a dynamic environment.
* Excellent communication skills for engaging with diverse stakeholders.
If interested and you meet many of the criteria, we encourage you to apply. Learn more about our diversity and inclusion efforts here and report for human rights information.
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