Safety Risk Engineer (m/f/d)

Philips International; Varginha; Presencial; BRL 120 000 - 190 000; Tempo integral

Resumo da oferta

Philips is seeking a Safety Risk Engineer to join the safety risk management team for hospital patient monitoring products. You will guide cross-functional teams, ensure compliance with ISO14971 and IEC standards, and own risk management documents in the technical file.

The role involves on-site collaboration at least three days per week and shaping post-release risk activities. You should have 5+ years in medical product development with 3+ years in safety risk management for active medical

Qualificações

• 5+ years proven experience in medical product development with 3+ years in safety risk management for active medical devices.
• Fundamental knowledge of regulations related to risk management and safe hardware/software products including ISO14971, FDA 21 CFR 820, EU MDR, IEC 60601-1, IEC 62304, IEC 62366-1.
• Solid methodology know-how: FMEA, FTA, PHA.
• Understanding of Safety Risk Engineering as an integrated discipline in a systems engineering workflow.
• Strong communication and moderation skills to lead cross-disciplinary discussions.
• University Degree in EE/ME/SW/Systems Engineering/Medical, Advanced English.

Responsabilidades

• 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 via creation and maintenance of risk management plans.
• Creation and maintenance of risk management matrices.
• Ensure completeness and quality of risk controls.
• Ensure traceability between risk management artifacts, requirements and verification.
• Work on-site at least 3 days a week.

Conhecimentos

Medical product development

Safety risk management

Software embedded systems

Advanced English

Formação académica

Bachelor/Master in EE/ME/SW/Systems Engineering/Medical

Ferramentas

FMEA

FTA

PHA

Descrição da oferta de emprego

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.

Learn more about our business. Discover our rich and exciting history. Learn more about our purpose.

#LI-OFFICE At Philips, we believe that every human matters.

As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.

For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners.

Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.

Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views.

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As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism.

To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

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