Safety Risk Engineer (m/f/d)

Philips; Varginha; Presencial; BRL 150 000 - 200 000; Tempo integral

Resumo da oferta

Philips in Varginha, Brazil, is seeking a Safety Risk Engineer to join their safety risk management team. You will be responsible for ensuring adherence to risk management processes and regulations for medical devices. The ideal candidate has over 5 years in medical product development with a strong emphasis on safety risk management. Strong communication skills and collaboration with cross-disciplinary teams are necessary for success. The position requires on-site presence at least 3 days a week.

Qualificações

• 5+ years proven experience in medical product development.
• 3+ years of experience in safety risk management for active medical devices.
• Fundamental knowledge of regulations related to risk management.

Responsabilidades

• Guide and facilitate safety risk management activities.
• Ensure adherence to process and applicable standards.
• Ownership of risk management documents in the technical file.

Conhecimentos

Safety risk management

Communication skills

Leadership

FMEA expertise

Formação académica

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

Descrição da oferta de emprego

Safety Risk Engineer (m/f/d)

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 an 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.