Philips

1 month ago

Safety Risk Engineer (m/f/d)

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 12 hours agoStatus: Live

Job Summary

Join Philips Hospital Patient Monitoring's safety risk management team to lead risk activities for platforms and products. You will ensure compliance with ISO14971, IEC standards, own risk management documents, and drive cross-functional risk decisions for software-intensive medical devices in an on-site role.

Location: Brazil

Workplace: Onsite

Employment Type: Full time

Job Function: Legal, Risk & Compliance

Key Responsibilities

•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 creating and maintaining risk management plans and matrices, ensuring completeness and quality of risk controls, and ensuring traceability between risk management artifacts, requirements and verification.

Key Requirements

•5+ years proven experience in medical product development with 3+ years of 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.

Experience:HealthcareMedical devicesEmbedded systems

Skills:CommunicationLeadershipFacilitation

Languages:English

Tech Stack:ISO14971IEC60601-1IEC62304IEC62366-1FMEAFTAPHA

Company Brief

Philips

Global health technology company focusing on diagnostic imaging, patient monitoring, and consumer health products. Philips develops medical devices, healthcare informatics, and solutions to improve patient care and personal well-being.

Industry: HealthTech

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Amsterdam, Netherlands

Founded: 1891

Glassdoor: 3.8

Website LinkedIn

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Philips

1 month ago

Safety Risk Engineer (m/f/d)

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 12 hours agoStatus: Live

Job Summary

Location: Brazil

Workplace: Onsite

Employment Type: Full time

Job Function: Legal, Risk & Compliance

Key Responsibilities

•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 creating and maintaining risk management plans and matrices, ensuring completeness and quality of risk controls, and ensuring traceability between risk management artifacts, requirements and verification.

Key Requirements

•5+ years proven experience in medical product development with 3+ years of 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.

Experience:HealthcareMedical devicesEmbedded systems

Skills:CommunicationLeadershipFacilitation

Languages:English

Tech Stack:ISO14971IEC60601-1IEC62304IEC62366-1FMEAFTAPHA

Company Brief

Philips

Industry: HealthTech

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Amsterdam, Netherlands

Founded: 1891

Glassdoor: 3.8

Website LinkedIn