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Philips

Product Safety & Risk Engineering Expert

Cambridge, MA

Job Title
Product Safety & Risk Engineering Expert

Job Description

At Philips, the safety of our customers and patients is our highest priority. The Product Safety Risk Engineering Expert will be an important member of the R&D Safety Risk Engineering team, ensuring Philips industry leading Hospital Patient Monitoring Systems/Products are safe, reliable, and compliant with all applicable regulatory/quality standards.

Your role:

  • The Product Safety Risk Engineering Expert will guide and facilitate safety risk management activities of a cross-functional team of experts, ensuring adherence to process and applicable standards like ISO14971, IEC 62366-1, IEC 82304, and IEC 62304.
  • Project responsibility for operational safety risk management activities such as: creation/maintenance of risk management plans/matrices, ensuring completeness/quality of risk controls and traceability between risk management artifacts, requirements, and verification.
  • Responsible for the risk management documents in the technical file, as well as post-release risk management activities.
  • Reporting to the Safety Risk Engineering Leader, you will collaborate with systems engineers and subject matter experts throughout the product development process.
  • This Hybrid, Cambridge, MA based role may require travel up to 10%.
You're the right fit if:

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  • You've acquired a Minimum of 7 years' experience in FDA regulated medical device product development, with a focus on product safety, risk management and compliance, for software driven systems/devices.
  • Your skills include expertise in Product Safety Risk Engineering as an integrated discipline in the systems engineering workflow, including strong knowledge in Risk Analysis Methodology (e.g., FMEA, FTA, PHA). Knowledge/experience in Software as a Medical Device (SaMD), Model Based Systems Engineering (MBSE), V-Model- desired.
  • You have In-depth knowledge of FDA regulations (ISO/IEC/CFR) related to risk management and the development of safe software products including ISO 14971, 21CFR 820, EU MDR, IEC 82304, IEC 62304, and IEC 62366-1
  • You have a Minimum of a Bachelor's Degree in Engineering (Required)-Systems, Computer Science/Engineering, Electrical , Biomedical Engineering or similar disciplines. Master's Degree desired.
  • You have excellent communication and moderation skills, with the ability to lead discussions with cross-disciplinary teams.
  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .
  • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
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. Do the work of your life to help improve the lives of others.
  • Learn more about our business .
  • Discover our rich and exciting history.
  • Learn more about our purpose.
  • Read more about our employee benefits .
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 .

Philips Transparency Details:

The pay range for this position is $120,000 to $223,000, annually. The actual base pay offered may vary depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

#LI-PH1

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.

Client-provided location(s): Cambridge, MA, USA
Job ID: Philips-515655
Employment Type: Full Time

Perks and Benefits

  • Health and Wellness

    • Health Insurance
    • Dental Insurance
    • Vision Insurance
    • Life Insurance
    • Short-Term Disability
    • Long-Term Disability
    • HSA
    • HSA With Employer Contribution
    • Fitness Subsidies
    • Pet Insurance
    • Mental Health Benefits
  • Work Flexibility

    • Flexible Work Hours
    • Remote Work Opportunities
    • Hybrid Work Opportunities
  • Office Life and Perks

    • Casual Dress
    • Snacks
    • On-Site Cafeteria
  • Vacation and Time Off

    • Paid Vacation
    • Paid Holidays
    • Personal/Sick Days
    • Volunteer Time Off
    • Summer Fridays
  • Financial and Retirement

    • 401(K) With Company Matching
    • Stock Purchase Program
    • Performance Bonus
  • Professional Development

    • Tuition Reimbursement
    • Promote From Within
    • Mentor Program
    • Shadowing Opportunities
    • Access to Online Courses
    • Lunch and Learns
  • Diversity and Inclusion

    • Diversity, Equity, and Inclusion Program
    • Employee Resource Groups (ERG)
    • Woman founded/led
    • Black founded/led
    • Latinx founded/led
    • Asian founded/led
    • LGBTQ+ founded/led
    • Veteran founded/led

Company Videos

Hear directly from employees about what it is like to work at Philips.