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 Needham, MA and key offices in Singapore and India. Join our team - we are Committed, Collaborative and Curious….we are Biofourmis!
Senior Systems Engineer
Biofourmis’ technology is applicable to a multitude of different therapeutics areas. We are building out a dramatically expanded of solutions to address heart failure, oncology, and infectious diseases. The Senior Systems Engineer will play a critical role in supporting the design, development, testing, and documentation of our solutions. This individual will support 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, loads 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.
- 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.
- 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 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 and automate Jira/Confluence
- Write and Review documentations for QMS
- Design and approve automated processes for product development
- Design and approve risk analysis, risk manage, Verification and Validation procedures
Requirements
- 3+ years experience working as a Systems Engineer on product design, development, and/or testing; experience with class II medical device products is preferred.
- Understanding of medical device product design and regulatory processes.
- Working knowledge of medical device regulates (21CFR820, European MDD, etc.)
- Able to communicate effectively, both verbally and in writing.
- Experience with medical device design and development processes that conform to standards including: ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971.
- Strong understanding of cloud solutions, mobile apps, medical devices.
- Technical understanding of and experience with best-practice product development methodologies.
- BS in Systems Engineering, Biomedical Engineering, Electrical Engineering, Computer Science, or Mechanical Engineering (or equivalent in a technical/scientific field); MS preferred
- Strong experience (1+ years) with Jira and Confluence
- Proficiency with Scrum/Agile methodology
