Product Safety & Risk Engineering Expert

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:

• 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 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, Biomedical Engineering or similar disciplines. Master's Degree desired.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position

How we work together:

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.

This is an office role.

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.
• Learn more about our culture.

Philips Transparency Details:

The pay range for this position in Cambridge, MA is $141,960 to $227,000.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information

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.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Cambridge, MA.

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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 including Disability/Vets and maintains a drug-free workplace.