📍 Job Overview

Job Title: Staff/Principal Systems Engineer
Company: DELFI Diagnostics, Inc.
Location: Remote
Job Type: Full-Time
Category: Systems Engineering - Medical Devices & Diagnostics
Date Posted: 2025-06-11
Experience Level: 10+ years
Remote Status: Remote

🚀 Role Summary

Key Responsibilities: Facilitate the development of DELFI's Bioinformatics Pipeline, contributing to the design, development, validation, and launch of NGS-based diagnostics software. Collaborate with cross-functional teams to define user needs and ensure compliance with regulatory standards.
Key Skills: Systems Engineering, Bioinformatics, Next-Generation Sequencing, Risk Management, Verification and Validation, Quality Compliance, Documentation, Agile Methodologies, Project Management, Cross-Functional Collaboration, Cancer Biology, Software Development, Stakeholder Communication, Process Improvement, Technical Writing, Regulatory Submissions.

💻 Primary Responsibilities

📝 Enhancement Note:

This role requires a strong background in systems engineering, with a focus on medical devices and diagnostics. Experience in bioinformatics and next-generation sequencing is highly desirable.

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.

🎓 Skills & Qualifications

Education: Bachelor's degree in a relevant field (Bioinformatics, Computational Biology, Computer Science, or related discipline). Master's or advanced degree preferred.

Experience: 8-10 years of experience in diagnostics or medical devices space, with 3-5 years specifically in systems engineering related to bioinformatics, next-generation sequencing, or cell-free DNA analysis.

Required Skills:

Proven experience in systems engineering, preferably in medical devices or diagnostics.
Strong understanding of bioinformatics pipelines, next-generation sequencing, and cell-free DNA analysis.
Experience with Agile software development methodologies, including Scrum and/or Kanban, and 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.

Preferred Skills:

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

📊 Web Portfolio & Project Requirements

Portfolio Essentials:

Demonstrate experience in systems engineering for medical devices or diagnostics through relevant projects and case studies.
Showcase your understanding of bioinformatics pipelines, next-generation sequencing, and cell-free DNA analysis through technical documentation and project presentations.
Highlight your ability to collaborate with cross-functional teams and stakeholders through project case studies and testimonials.

Technical Documentation:

Provide examples of software requirements documents, risk assessments, and validation plans for medical device software development projects.
Include documentation on regulatory compliance, including GxP, HIPAA, IEC 62304, and 21 CFR 820 standards.
Showcase your ability to create and manage technical documents under design control and quality management systems.

💵 Compensation & Benefits

Salary Range: $210,000 - $250,000 a year

Benefits:

An equal opportunity employer. DELFI Diagnostics is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

🎯 Team & Company Context

🏢 Company Culture

Industry: Medical Devices & Diagnostics

Company Size: Small to Medium-sized (50-250 employees)

Founded: 2021 (Johns Hopkins spinoff)

Team Structure:

The Systems Engineering team works closely with cross-functional teams, including Data Science, Assay, Lab Operations, and other departments.
The team follows Agile methodologies, with a focus on collaboration, continuous improvement, and customer value.
The company values diversity, inclusion, and a mission-driven culture focused on curing cancer through high-performance, accessible early cancer detection.

Development Methodology:

DELFI Diagnostics follows Agile software development methodologies, with a focus on Scrum and Kanban.
The company prioritizes collaboration, continuous improvement, and customer value in its development processes.
DELFI Diagnostics is committed to maintaining high-quality standards and regulatory compliance in its software development lifecycle.

Company Website: delfidiagnostics.com

📈 Career & Growth Analysis

Web Technology Career Level: Senior Systems Engineer - Medical Devices & Diagnostics

Reporting Structure: The Staff/Principal Systems Engineer reports directly to the Director of Software Engineering and works closely with cross-functional teams, including Data Science, Assay, Lab Operations, and other departments.

Technical Impact: This role has a significant impact on the development and maintenance of DELFI's Bioinformatics Pipeline, ensuring the software meets regulatory requirements and delivers high-quality, accurate results for cancer detection.

Growth Opportunities:

Technical Growth: Deepen your expertise in systems engineering for medical devices and diagnostics, with a focus on bioinformatics pipelines, next-generation sequencing, and cell-free DNA analysis.
Leadership Growth: Develop your leadership skills by mentoring junior team members, driving process improvements, and contributing to strategic decision-making.
Career Progression: Advance your career by taking on more significant responsibilities, such as managing teams or leading projects, or by exploring opportunities in related fields, such as regulatory affairs or quality assurance.

🌐 Work Environment

Office Type: Remote work environment with occasional on-site meetings and collaboration sessions.

Office Location(s): Remote - Global

Workspace Context:

Remote Work: DELFI Diagnostics offers a remote work environment, allowing for flexible scheduling and work-life balance.
Collaboration Tools: The company uses Jira for agile development tracking and Smartsheet for project planning and cross-functional coordination.
Cross-Functional Collaboration: DELFI Diagnostics encourages collaboration between teams and departments, fostering a culture of shared learning and continuous improvement.

Work Schedule: Full-time, with flexible hours and the ability to work remotely.

📄 Application & Technical Interview Process

Interview Process:

Resume Review: The hiring manager will review your resume and portfolio for relevant experience and qualifications.
Phone/Video Screen: A brief phone or video call to discuss your background, experience, and career goals.
Technical Interview: A deeper dive into your systems engineering experience, with a focus on medical devices, diagnostics, and bioinformatics. Be prepared to discuss your approach to risk management, verification and validation, and quality compliance.
Final Interview: A conversation with the hiring manager or other senior team members to assess cultural fit and discuss the role's expectations and growth opportunities.

Portfolio Review Tips:

Highlight your experience in systems engineering for medical devices or diagnostics through relevant projects and case studies.
Showcase your understanding of bioinformatics pipelines, next-generation sequencing, and cell-free DNA analysis through technical documentation and project presentations.
Include examples of your ability to collaborate with cross-functional teams and stakeholders, demonstrating your communication and leadership skills.

Technical Challenge Preparation:

Brush up on your knowledge of systems engineering principles, with a focus on medical devices, diagnostics, and bioinformatics.
Review your understanding of risk management, verification and validation, and quality compliance in the context of medical device software development.
Prepare for behavioral interview questions that assess your problem-solving skills, communication, and leadership abilities.

ATS Keywords: Systems Engineering, Medical Devices, Diagnostics, Bioinformatics, Next-Generation Sequencing, Cell-Free DNA Analysis, Risk Management, Verification and Validation, Quality Compliance, Agile Methodologies, Project Management, Cross-Functional Collaboration, Cancer Biology, Software Development, Stakeholder Communication, Process Improvement, Technical Writing, Regulatory Submissions, GxP, HIPAA, IEC 62304, 21 CFR 820, AI in Medical Devices.

🛠 Technology Stack & Web Infrastructure

Systems Engineering Tools:

Jira (Agile development tracking)
Smartsheet (project planning and cross-functional coordination)
Microsoft Office Suite (documentation and reporting)
Git (version control)
JIRA Software (project management)

Bioinformatics Tools:

Next-generation sequencing platforms (e.g., Illumina, Ion Torrent, PacBio)
Bioinformatics software suites (e.g., BWA, SAMtools, BCFtools, GATK, Picard)
Programming languages (Python, R)
Data analysis and visualization tools (RStudio, Jupyter Notebooks, Tableau)

Medical Device Software Development Tools:

Medical device software development platforms (e.g., MATLAB, Simulink)
Regulatory compliance tools (e.g., 21 CFR Part 11, HIPAA, IEC 62304, 21 CFR 820)
Quality management systems (e.g., ISO 13485, FDA Quality System Regulation)

👥 Team Culture & Values

Web Development Values:

Lead with Science, Anchor in Pragmatism: DELFI Diagnostics prioritizes rigorous, transparent, and high-quality science in all aspects of its work.
Build With & For All: The company values diversity, inclusion, and collaboration, striving to create products that benefit all patients, regardless of geography or socioeconomic class.
Put We over I: DELFI Diagnostics fosters a culture of teamwork, collective intelligence, and shared success, with a focus on empathy, humility, and integrity.

Collaboration Style:

Cross-Functional Integration: DELFI Diagnostics encourages collaboration between teams and departments, fostering a culture of shared learning and continuous improvement.
Code Review Culture: The company values peer review and feedback, with a focus on knowledge sharing and technical mentoring.
Knowledge Sharing: DELFI Diagnostics prioritizes continuous learning and skill development, with a focus on emerging technologies and best practices in medical device software development.

⚡ Challenges & Growth Opportunities

Technical Challenges:

Regulatory Compliance: Ensure that DELFI's Bioinformatics Pipeline meets regulatory requirements, including GxP, HIPAA, IEC 62304, and 21 CFR 820 standards.
Risk Management: Identify and mitigate risks associated with the development, validation, and deployment of medical device software.
Verification and Validation: Design and execute verification and validation activities to ensure the software meets user needs and regulatory requirements.
Cross-Functional Collaboration: Work effectively with cross-functional teams, including Data Science, Assay, Lab Operations, and other departments, to gather and prioritize software requirements and drive software release activities.

Learning & Development Opportunities:

Technical Skill Development: Deepen your expertise in systems engineering for medical devices and diagnostics, with a focus on bioinformatics pipelines, next-generation sequencing, and cell-free DNA analysis.
Leadership Development: Develop your leadership skills by mentoring junior team members, driving process improvements, and contributing to strategic decision-making.
Career Progression: Explore opportunities for career advancement, such as taking on more significant responsibilities, managing teams, or leading projects, or by pursuing related fields, such as regulatory affairs or quality assurance.

💡 Interview Preparation

Technical Questions:

Systems Engineering Fundamentals: Discuss your approach to systems engineering for medical devices and diagnostics, with a focus on bioinformatics pipelines, next-generation sequencing, and cell-free DNA analysis.
Risk Management: Describe your experience with risk management in medical device software development, including hazard analyses, FMEAs, and implementation of risk control measures.
Verification and Validation: Explain your approach to verification and validation in medical device software development, including design verification, installation qualification, operational qualification, and performance qualification.
Quality Compliance: Discuss your understanding of regulatory standards, including GxP, HIPAA, IEC 62304, and 21 CFR 820, and your experience ensuring compliance in medical device software development.

Company & Culture Questions:

Company Mission: Explain why you are drawn to DELFI Diagnostics' mission to cure cancer through high-performance, accessible early cancer detection.
Company Culture: Describe what aspects of DELFI Diagnostics' culture appeal to you and how you would contribute to the team's success.
Cross-Functional Collaboration: Discuss your experience working with cross-functional teams and your approach to building positive stakeholder relationships.

Portfolio Presentation Strategy:

Project Selection: Choose projects that demonstrate your experience in systems engineering for medical devices or diagnostics, with a focus on bioinformatics pipelines, next-generation sequencing, and cell-free DNA analysis.
Technical Deep Dive: Prepare a detailed technical presentation that walks through your approach to risk management, verification and validation, and quality compliance in medical device software development.
User Impact: Highlight the user impact of your work, including improvements to cancer detection, patient outcomes, and healthcare accessibility.

📌 Application Steps

To apply for this Staff/Principal Systems Engineer position:

Tailor Your Resume: Highlight your relevant experience in systems engineering for medical devices or diagnostics, with a focus on bioinformatics pipelines, next-generation sequencing, and cell-free DNA analysis.
Prepare Your Portfolio: Include examples of your work that demonstrate your understanding of risk management, verification and validation, and quality compliance in medical device software development.
Research the Company: Familiarize yourself with DELFI Diagnostics' mission, culture, and values, and be prepared to discuss how you would contribute to the team's success.
Prepare for Technical Interviews: Brush up on your knowledge of systems engineering principles, with a focus on medical devices, diagnostics, and bioinformatics. Review your understanding of risk management, verification and validation, and quality compliance in the context of medical device software development.

📝 Enhancement Note: This enhanced job description includes AI-generated insights and web development/server administration industry-standard assumptions. All details should be verified directly with the hiring organization before making application decisions.

Staff/Principal Systems Engineer