Senior Risk Engineer (NPI, Medical Devices)

Job Title

Senior Risk Engineer (NPI Medical Devices)

Job Description

Senior Risk Engineer (NPI Medical Devices)

In late January we announcedthat 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 Bridgefields 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 youll 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

Youre right for this role if :

You Bachelors / Masters 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 youre 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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Required Experience :

Senior IC

Key Skills

Diploma,DCS,ABAP,Application Development,Irrigation,Bakery

Employment Type : Full-Time

Experience : years

Vacancy : 1