SimBioSys is on a mission to improve patient experience through computational simulations. By virtualizing cancer, clinicians and patients are empowered with a better understanding of the disease and can assess all available options computationally to truly individualize treatment. We employ a combination of biophysical modeling and artificial intelligence to enable precision medicine in Oncology. Our portfolio of software applications enables individualized cancer care, drug development, clinical trial optimization and comprehensive biomarker development.

The Staff/Sr. Staff Software Design Control Engineer thinks “outside the box” in the execution of the Software Design Control and SDLC (software development lifecycle) programs at SimBioSys, providing quality oversight, and ensuring compliance with all applicable regulations and incorporations of software industry best practices. The position will report to the VP Regulatory & Quality and will work in collaboration with the Software Development, Deep Learning, IT, Regulatory Affairs, project/program management, and other cross-functional teams throughout the SDLC.

Job Responsibilities

  • Execution of the SDLC and software design controls as per the requirements of ISO 13485/FDA QSR design controls and IEC 62304.
  • Maintain software design control and SDLC SOPs, work instructions and templates.
  • eDHF: Manage the execution of eQMS tools for design controls and risk management, including SDLC tools for semi-automation of design controls and DHF deliverables.
  • Provide mentorship, guidance and training to the software development teams new to medical device design controls.
  • Leading by example. Provide review and approvals, and as necessary authoring of, software DHF deliverables such as software development, risk management and V&V plans; requirements and specification (SRS, SDS); code reviews; test (unit, integration, and system) protocols and reports; and SOUP/OTS.
  • Lead the cross-functional product development teams in performing risk management activities such as dFMEA and cybersecurity risk analysis.
  • Develop/Maintain agile processes for software change controls for frequent, iterative releases for design changes throughout SDLC.
  • Support CSV (Computer System Validation) activities as per GAMP5.
  • Assist in regulatory inspection readiness activities and provide support during regulatory site inspections.
  • Participate in process improvement initiatives as necessary, performing gap analysis and risk communication.
  • Perform complaint investigations, root cause analysis, CAPA, closure of audit/inspection observations, and other QMS activities related to software design controls and risk management.

Required Qualifications

  • Bachelor’s degree in an engineering, scientific or related field with minimum 5-8+ years of relevant management and hands-on experience, or relevant comparable background.

Preferred Qualifications

  • Expert knowledge of SDLC and the application of IEC 62304 to meet the design controls and risk management requirements of ISO 13485, FDA QSR/21 CFR Part 820, ISO 14971; working knowledge of IVDR and CAP/CLIA preferred.
  • Solid knowledge of agile/scrum SDLC methodology and its implementation within medical device design controls.
  • Experience with agile SDLC tools.
  • Knowledge of CSV (Computer System Validation), GAMP5 and 21 CFR Part 11 requirements.
  • Experience in successfully leading new software development teams through the design controls and risk management processes, including DHF documentation.
  • Adaptable to fast-paced, dynamic work environment with shifting demands.
  • Experience in supporting regulatory inspections.

Core Skills & Competencies

  • Experience in successfully leading new product development project teams through the design controls and risk management process, including all requirements and documents.