Director Systems Engineering

Biofourmis is a rapidly growing, global digital health company filled with committed, passionate professionals who care about augmenting personalized care and empowering people with complex chronic conditions to live better and healthier lives. We are pioneering an entirely new category of medicine by developing clinically validated, software-based therapeutics to provide improved outcomes for patients, smarter engagement & tracking tools for clinicians, and cost-effective solutions for payers. We are collectively devoted to a single-minded idea: powering personally predictive care.

Our dynamic growth has been marked by quadrupled headcount in the last 12 months via both expansion & acquisition, yielding a global footprint with offices in Boston, Singapore, Bangalore, and Zurich. We are backed by prominent international venture capital investment & have cultivated relationships with worldwide healthcare stakeholders over the last 5 years. Our talented team features numerous PhD's in Data Science and Biostatistics, over 80 patents, prolific scientific publications, world-class systems, developers & engineers, and leaders in the clinical operations space.

Director, Systems Engineering

Biofourmis' technology is applicable to a multitude of different therapeutic areas. We are building out a dramatically expanded of solutions to address heart failure, oncology, and infectious diseases. The Director of Systems Engineer will play a critical role in leading the design, development, testing, and documentation of our solutions. This individual will lead systems engineering-related activities on product development programs, demonstrating outstanding written and verbal technical communications skills.

Responsibilities

• Support systems engineering efforts for a complex, data-science driven, turnkey medical solution that spans a hardware device, mobile phone apps, and cloud backend; responsibilities 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 to create, update, and maintain documentation that is or will become part of the product design history file (DHF) for a medical therapeutics solution.
• Mentor a team of systems engineers to ensure that engineering and quality processes are implemented effectively and consistently across all product lines.
• Support the development and maintenance of product architecture, product specifications, requirements documents, hazards analysis documents, usability and V&V documentation, and other technical documentation.
• Conduct Risk Management activities to ensure that design and process shortcomings are identified and appropriately addressed.
• Perform Risk Analyses, including Fault Tree Analysis (FTA), Operator Misuse Analysis (OMA), and Failure Mode and Effects Analysis (FMEA) activities when applicable.
• 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.
• Owns and drives resolution of design issues/defects
• Works with the QA team to specify and document product tests for compliance to regulatory standards.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Respond rapidly and flexibly to emerging issues in production, quality, and engineering,
• Manage a comprehensive solution for capturing requirements, traceability, verification testing suite
• Write and Review documentation for QMS
• Design and approve automated processes for product development
• Design and approve risk analysis, risk management, Verification, and Validation procedures
• Works closely with the VP of Systems Engineering to identify and drive toward team-wide metrics
• Actively participate in attracting, selecting, retention, and developing the team.
• Exercises judgment within defined procedures and practices to determine appropriate action.

Requirements

• 5+ years experience managing technical teams in the development of medical device software.
• Experience shipping and supporting commercial software products to the field.
• Experience working with Jama, Jira/Confluence at the customization level.
• Experience leading, mentoring, and growing a software development team.
• Experience working in Agile development environments.
• Demonstrated commitment to high quality.
• Bachelor's degree in computer science or related engineering discipline.