Principal Systems Engineer

Summary

Join Delfi Diagnostics, a Johns Hopkins spinoff, as a Systems Engineer to contribute to the development of their bioinformatics pipeline for early cancer detection. This role involves cross-functional collaboration, focusing on requirements management, stakeholder communication, roadmap management, risk mitigation, verification and validation, and regulatory compliance. You will translate user needs into product requirements, prioritize features, and ensure alignment with GxP, HIPAA, and other relevant standards. The position requires experience in diagnostics or medical devices, bioinformatics pipelines, and agile methodologies. Success in this role will involve improving the bioinformatics pipeline, optimizing software development processes, and leading cross-functional teams. The ideal candidate will have a strong understanding of next-generation sequencing and regulatory submissions.

Requirements

• 8-10 years of experience in diagnostics or medical devices space
• 3-5 years of experience in systems engineering experience preferably in Bioinformatics pipelines, next-generation sequencing, cell-free DNA analysis
• Bachelor's degree in a relevant field (Bioinformatics, Computational Biology, Computer Science, or related discipline). Master's or advanced degree preferred
• Experience with Agile software development methodologies, including Scrum (sprint planning, daily standups, retrospectives) and/or Kanban, with ability to adapt processes to regulated environments
• Experience with workflow and project management tools, specifically Jira for agile development tracking and Smartsheet for project planning and cross-functional coordination
• Experience with development projects intended to lead to US-IVD regulatory submissions such as 510(k), de novo, or PMA
• Basic understanding of next-generation sequencing and bioinformatics concepts
• Demonstrated ability to author clear and detailed software requirements
• Exceptional cross-functional communication skills with a proactive, solution-oriented mindset and demonstrated ability to build positive stakeholder relationships

Responsibilities

• Requirements Management : Translate user needs and customer requirements into product and systems requirements and specifications, ensuring optimal implementation into product design
• Stakeholder Collaboration : Collaborate with stakeholders in Data Science, Assay, Lab Operations, and other departments to gather and prioritize software requirements and drive software release activities
• Strategic Roadmap Management : Maintain software and systems roadmaps that balance maintenance and routine upgrades, new features, system architecture considerations, and regulatory requirements
• Risk Management : Participate in risk management activities, including hazard analyses, FMEAs, and implementation of risk control measures
• Verification and Validation : Partner with the Software Quality and Testing teams to help design and execute verification and validation activities
• Quality and Compliance : Ensure product and system development aligns with GxP (including 21 CFR Part 11), HIPAA compliance requirements, and where applicable, IEC 62304 and 21 CFR 820 standards. Remain abreast of evolving regulatory guidelines on the use of AI in medical devices, and implement such guidelines in practice
• Documentation and Regulatory Support : Develop and document work under design control and quality management systems, policies, and procedures. Support regulatory submission activities through creation, review, and management of 21 CFR 820-compliant technical documents
• Process Improvement : Document current processes, system configurations, challenges, and opportunities while establishing efficient and fit-for-purpose workflows for the software and system development lifecycle
• Leadership : Exemplify and champion design control and systems engineering values and techniques
• Facilitated the development and continuous improvement of bioinformatics pipeline software and integrated systems within a regulated environment
• Developed and maintained roadmaps, defined user and system needs, and optimized software development processes for bioinformatics pipeline
• Led a cross-functional team to establish requirements and design outputs for bioinformatics pipeline software, representing software expertise, judgment, and strategic vision in stakeholder meetings
• Established a robust software and system requirements management system aligned with regulatory standards
• Participate in Failure Mode and Effects Analyses (FMEAs) and facilitate the implementation of risk control measures to ensure software quality and patient safety

Preferred Qualifications

• Experience as a systems engineer in medical device software development
• Experience in engineering design frameworks (e.g., Robust Design, Design For Six Sigma)
• Some familiarity with technical subject matter: Cancer biology, cancer diagnostics or screening and Python and R programming languages

Benefits

$210,000 - $250,000 a year