Principal Systems Engineer

Biofourmis' technology is applicable to a multitude of different therapeutic areas. We are building out dramatically expanded solutions to address heart failure, oncology, and infectious diseases. The Principal Systems Engineer will have a critical role in the design, development, testing, and documentation of our innovative solutions. This individual will contribute and/or lead systems engineering-related activities on cross functional product development programs, demonstrating technical and regulatory expertise as well as outstanding written and verbal communications skills.

Responsibilities

• Support systems engineering efforts for complex, data-science driven, turnkey medical solutions that span hardware devices, mobile phone apps, and cloud backend; responsibilities for supporting and reporting on all phases of the product development and operations lifecycle including hardware assembly and integration, software builds, releases and updates, configuration control, requirements, design, and test execution.
• Collaborate with a diverse technical team in the creation, update, and maintainance of documentation that is or will become part of the product design history file (DHF) for medical therapeutics solutions.
• Conduct Risk Management activities to ensure that design and process shortcomings are identified and appropriately addressed using tools such as Fault Tree Analysis (FTA), Operator Misuse Analysis (OMA), and Failure Mode and Effects Analysis (FMEA) activities when applicable.
• Facilitate transparent communication between teams and stakeholders, providing regular project updates and metrics addressing any technical or scheduling challenges.
• Work with subsystem teams and domain subject matter experts in the identification, logging, assessment, and resolution of integration and test issues.
• Provide technical guidance for product design, development, integration, testing, and reliability improvements.
• Provide input for submissions to regulatory bodies and governmental agencies.
• Works with the RA/QA team to ensure product and procedural compliance to regulatory standards.
• Respond rapidly and flexibly to emerging issues in production, quality, and engineering.
• Help manage a comprehensive solution for capturing requirements, traceability, verification and validation testing suite
• Identify, champion and drive formal and informal process improvement efforts.
• Own and lead execution and closure of CAPAs and NCRs

Requirements

• Bachelor's degree in computer science or related engineering discipline with 7 years of experience developing highly complex systems
• Demonstrated track record in driving and delivering results and adapting to shifting priorities within a dynamic fast paced environment.
• Successful history of launching and maintaining products within the medical device industry
• Demonstrated expertise of SDLC, Computer System Validation/Assurance, Design Controls, systems engineering principles, requirements management and medical device QMS regulations including ISO 13485, ISO 14971and 21CFR 820.30 Design Controls and 21 CFR 820.70 Production and Process Controls..
• Demonstrated expertise in design, development and testing of software based medical devices.
• Working knowledge of hardware, firmware and software evaluation to standards IEC 62304, 60601-1-8, 21CFR Part 11 and ICH E6 Good Clinical Practice.
• Experience working with requirement management, collaboration and issue tracking tools such as Jama, Jira, Confluence at the customization level.
• Significant experience working with agile software development methods such as Scrum and Kanban and exposure to working within CI/CD pipelines.
• Experience leading and mentoring junior engineers and team members.
• Experience with cyber security and privacy policies and design requirements.
• Experience with performance and reliability test strategies and tools.