Tidepool has kicked off a project to build and support an FDA-regulated version of Loop, to be available in the iOS App Store, intended to work with commercially available insulin pumps and CGMs as an automatic insulin dosing (AID) system. As System Safety Engineer, you will play a key role in ensuring that the product is safe to use, and meets all regulatory compliance requirements.
- Conduct preliminary hazard analyses and sub-system analyses to identify top level safety requirements and to assess system architecture and designs.
- Work closely with engineering team members to develop hazard mitigations and mitigation verification strategies needed to drive safety in design.
- Participate in design reviews and discussions to help ensure that safety goals and requirements are being effectively addressed.
- Work closely with product management, engineering, security and regulatory team members to evaluate potential safety issues that arise from the field or from testing as well evaluating safety regulatory compliance issues.
- Work closely with our medical device manufacturing partners to align risk management practices.
- Assist in resolving conflicts between safety requirements and other system requirements within the product engineering teams and escalate issues as appropriate.
- Support safety process improvements as needed to improve a robust system safety process and to develop system safety best practices for software-as-medical-device (SaMD) and medical devices.
The ideal candidate has:
- Bachelor of Science in Engineering, Computer Science or related technical degree plus 5 years relevant engineering work experience that includes some system safety engineering. Advanced degree in engineering or related technical field is preferred
- Experience in performing hazard analyses, for example Preliminary Hazard Analysis (PrHA), Subsystem Hazard Analyses (SSHA), Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), Systems Theoretic Process Analysis (STPA)
- Domain expertise in safety analysis of software-as-medical-device systems (SaMD) is highly desirable
- Hands-on experience in software development, software safety, and/or software verification and validation is desirable
- Experience in evaluating and ensuring regulatory compliance, e.g. with ISO 14971, is desirable
- Experience in investigating and conducting engineering analysis of safety related field failures is desirable
- Experience with regulatory compliance agencies in multiple jurisdictions, such as the FDA and CE Mark Notifying Bodies, is desirable
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