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Philips

Safety Risk Engineer (m/f/d)

Philips is hiring a Safety Risk Engineer (m/f/d). Level rates it ; you can apply on Philips.

Level's read on this job

  • On Level's scale, this role is Little AI ●○○○: aI is not part of the work.
  • Tools and skills the posting cites include safety risk management, fmea and fta.
  • Level classifies it as a senior role.
  • Level lists 809 other open roles at Philips.

AI in this role

Conduct safety risk management activities for medical patient monitoring products in compliance with regulatory standards.

safety-risk-managementfmeaftaiso14971iec60601-1

Job Title

Safety Risk Engineer (m/f/d)

Job Description

In this role you will become a member of our safety risk management team. As part of this team, you are responsible for the safety risk management of platforms and products of the Philips Hospital Patient Monitoring business.

Your role:

  • Guide and facilitate safety risk management activities of a cross-functional expert team

  • Ensure adherence to process and applicable standards like ISO14971, IEC62366-1, IEC60601-1, and IEC 62304

  • Ownership of the risk management documents in the technical file

  • Contribute to post-release risk management activities

  • Take operational responsibility for safety risk management in projects by

    • Creation and maintenance of risk management plans

    • Creation and maintenance of risk management matrices

    • Ensuring completeness and quality of risk controls

    • Ensuring traceability between risk management artifacts, requirements and verification

You should bring the following:

  • 5+ years proven experience in medical product development with 3+ years of experience in safety risk management for active medical devices preferably for software intense embedded systems.

  • Fundamental knowledge of regulations related to risk management and the development of safe hardware and software products including ISO14971, FDA Regulations 21CFR 820, EU MDR, IEC 60601-1, IEC 62304, and IEC 62366-1.

  • Solid methodology know-how: e.g. FMEA, FTA, PHA.

  • Understanding of Safety Risk Engineering as integrated discipline in a system engineering workflow.

  • Strong communication and moderation skills to lead discussions of cross-disciplinary teams.

  • University Degree Bachelor / Master (EE/ME/SW/Systems Engineering/Medical)

  • Advanced English

How We Work Together

We believe that we achieve better results when we work together rather than apart. For this role this means to be on-site at least 3 days a week.


About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. With patient safety and Quality as our fundamental premise, we focus on regulatory requirements and quality standards in our daily work. Do the work of your life to help the lives of others.

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.

#LI-OFFICE

How we rate this

Safety Risk Engineer (m/f/d) at Philips rates 0 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.

Classification

Little AI. AI is not part of the work.

  1. ●●●● Builds AI80 to 100
  2. ●●●○ Works on AI60 to 79
  3. ●●○○ Uses AI40 to 59
  4. ●○○○ Little AI0 to 39

Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.

Prepare for this job

Built from this posting and from similar jobs on Level.

Skills and AI tools this role asks for

Safety Risk ManagementFmeaFtaIso14971Iec60601 1

Questions you could be asked

  1. Tell me about a project where safety risk management was part of your work. What did you do?
  2. Tell me about a project where fmea was part of your work. What did you do?
  3. Tell me about a project where fta was part of your work. What did you do?
  4. Tell me about a project where iso14971 was part of your work. What did you do?
  5. Tell me about a project where iec60601 1 was part of your work. What did you do?

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  • List these exact terms on your resume: Safety Risk Management, Fmea, Fta, Iso14971, and Iec60601 1. An applicant tracking system matches the wording, not the idea.
  • Attach one line of real, concrete experience to at least one of them. A tool named with nothing behind it rarely survives a human read.

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