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:

　　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.

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　　It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.

　　As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation 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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