Biofourmis brings the right care to every person, no matter where they are. The company’s AI-driven solution collects and analyzes patient data in real time and identifies shifts that require proactive interventions. This vital innovation provides people everywhere with connected access to hospital-level services, virtual provider networks for remote care, and life-changing clinical trials—all without leaving their homes. Trusted by leading health systems, payers, biopharma companies and patients alike, Biofourmis’ connected platform improves patient outcomes, prevents hospital readmissions, accelerates drug development, and closes critical gaps in care—ultimately making science smarter, healthcare simpler, and patients healthier. Biofourmis is a global technology company enabling care delivery, with headquarters in Boston and key offices in Singapore and India.
Director, Verification and Validation
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 Director of Verification and Validation will play a hands on, critical role in ensuring engineering requirements, design outputs, verification and validation testing and documented evidence meet all medical device quality management system regulations and standards relative to design controls for the design, development and manufacturing of our innovative solutions. This individual will lead V&V activities on cross functional product development programs, demonstrating technical and regulatory expertise as well as outstanding written and verbal communications skills.
Responsibilities
- Support all aspects of Verification/Validation and QA 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.
- Develop and implement comprehensive test strategy for effective V&V as well as QA/Engineering testing while ensuring efficiency, synergy, scalability and compliance across all platforms.
- Develop test methodology, verification/validation plans and protocols, requirement traceability matrices, test reports and summary reports in collaboration with cross functional team utilizing throrough knowledge of statistics, sample size determination documenting justifications/rationale and statistical data analysis of results.
- Manage a comprehensive solution for capturing traceability, verification and validation testing suite.
- Lead a team of V&V and Quality Engineers for continuous updates, maintenance, execution and reporting of V&V protocols and engineering test suites.
- Lead and perform required tool validations and ensure test scripts, protocols and reports are properly reviewed and approved per design control and QMS processes.
- Lead the evaluation, selection implementation and maintenance of test management and automation tools.
- Collaborate with a diverse technical team for the creation, update, and maintainance of documentation that will become part of the product design history file (DHF) for medical therapeutics solutions.
- Collaborate on 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.
- Owns and drives resolution of design issues/defects
- Works with the QA team to specify and document product tests for compliance to regulatory standards.
- Respond rapidly and flexibly to emerging issues in production, quality, and engineering.
- 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
- Works closely with the VP of Systems Engineering to identify and drive toward team-wide metrics
- Cultivate a culture of continuous improvement by staying informed about industry trends, technological advancements, and emerging tools in medical device V&V, human factors, design controls, reliability testing, and software development.
- Build and mentor a team of V&V engineers to ensure that engineering and quality processes are implemented effectively and consistently across all products.
- Actively participate in attracting, selecting, retention, and developing the team.
Requirements
- Bachelor's degree in computer science or related engineering discipline with 10+ years of experience developing highly complex systems
- 5+ years experience managing technical teams in the development of medical device software.
- Demonstrated track record in driving results, managing complex projects, nurturing team culture, 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, Design Controls, systems engineering principles, requirements management, test 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 and 21CFR Part 11 and ICH E6 Good Clinical Practice.
- Experience working with requirement management, test 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 growing a V&V engineering team including recruiting, hiring, mentoring, professional development, and performance reviews
- Experience with cyber security and privacy policies and design requirements.
- Experience with performance and reliability test tools and strategies.
- Demonstrated experience with selection and implementation of test automation frameworks.
