Staff Systems Engineer

About Us

DELFI Diagnostics, Inc. (DELFI Diagnostics) is developing next-generation, blood-based tests that are reliable, accessible and deliver a new way to help detect cancer. Employing advanced machine-learning methods to whole-genome sequencing data, the DELFI ("DNA EvaLuation of Fragments for early Interception") platform is built to address the highest-burden health challenges. DELFI Diagnostics prioritizes solutions that have the potential to save lives on a global scale, including for historically underserved populations. DELFI Diagnostics’ platform relies on fragmentomics – the discovery that cancer cells are more chaotic than normal cells and, when they die, leave behind tell-tale patterns and characteristics of cell-free DNA (cfDNA) fragments. FirstLook Lung, for individuals eligible for lung cancer screening, is DELFI Diagnostics’ first laboratory-developed screening test and can be part of routine blood work. FirstLook Lung uses millions of data points to reliably identify individuals who may have cancer detected through low-dose CT, including early stage disease with a negative predictive value of 99.8 percent. This test has not been cleared or approved by the FDA.

In our passionate pursuit to radically improve health outcomes, we serve humanity when we:

Lead with Science, Anchor in Pragmatism: We pioneer life-changing science by ensuring quality, transparency, and rigor at all times. We explore thoughtfully, experiment smartly, and deliver impact with conviction.

Build With & For All: We embrace diverse backgrounds to innovate and achieve together. We are not just building a product - we aim to disrupt the path of cancer for all - no matter geography or socioeconomic class 

Put We over I: We are a home for high-performing people. Through teamwork, we build collective intelligence. Each of us wins when those we serve and those who serve with us--win. We show up with empathy, humility, and integrity at every step of the journey.

DELFI has 1-2 designated in-office working days each week for employees who live within within 50 miles of Palo Alto CA or Baltimore MD offices

The Staff Systems Engineer at DELFI Diagnostics will directly contribute to the efforts to design, develop, validate, and launch automated NGS-based diagnostics aimed at early cancer detection. This position works as part of an outstanding cross-functional team to define user needs, translate product requirements, create specifications, identify and mitigate risks, lead verification and validation activities, and contribute to FDA submissions.

Remote candidates may be considered based on competitive qualifications.

• Translate user needs and customer requirements into product requirements and specifications, and ensure optimal implementation into product design
• Create and maintain Design and Development Plans throughout the product development lifecycle. Assist technical SMEs in creating and maintaining technical development plans
• Lead risk management activities, including hazard analyses, FMEAs, and implementation of risk control measures
• Partner with cross functional representatives in assay development, bioinformatics, and laboratory operations to facilitate trade-off decisions and deliver on business goals through construction of design budgets and quantitative models
• Work with engineering and laboratory teams to troubleshoot and resolve issues and find solutions for common failure modes Lead root cause investigations using 5 Whys, Fishbone, Fault Tree Analysis, or similar techniques. Provide expertise in statistical methods appropriate for troubleshooting and development studies, including design of experiments (DOE) methodology. Document investigations in associated non-conformance reports or corrective and preventive action reports
• Partner with cross-functional representatives in assay development, bioinformatics, and commercial to develop, document, and/or iterate engineering design outputs, including specifications, workflow diagrams, and bills of material. Partner with cross-functional representatives to derive and document quality control specifications, equipment, and reagent qualification methods. Create and maintain the Device Master Record. Support design transfer activities
• Support product development, design verification, and design validation activities through authorship of test plans, protocols and reports associated with development, verification, and validation and maintenance of the traceability matrix
• 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
• Exemplify and champion design control and systems engineering values and techniques

• Become an expert on DELFI’s technology and processes
• Lead a cross-functional team to establish requirements and design outputs for a new in vitro diagnostic product
• Establish performance budgets and facilitate trade decisions associated with development of a new in vitro diagnostic product
• Establish FMEAs and lead the implementation of risk control measures associated with a new in vitro diagnostic product
• Establish verification and validation plans that incorporate existing analytical and clinical validation frameworks for a new in vitro diagnostic product

• BS or MS in a relevant engineering field (e.g., Systems Engineering, Biomedical Engineering, Biological Sciences, or related fields)
• Minimum of 12- years (BS), 10 years (MS), or 5 years (PhD) of direct experience in systems or process engineering in a regulated product development setting
• Experience with 21 CFR 820 and ISO 13485-compliant quality management systems
• Experience carrying out ISO 14971-compliant risk management activities
• Experience with development projects intended to lead to US-IVD regulatory submissions such as 510(k), de novo, or PMA
• Experience with requirements elicitation and management of traceability matrices
• High level of analytical competence and demonstrated ability to solve complex technical problems using systems engineering techniques and statistical methods
• Excellent skills in technical and non-technical communication in oral and written formats
• Ability to master new concepts and skills quickly, with strong attention to detail

• Expertise in next generation sequencing or highly multiplexed proteomics techniques in high-throughput settings
• Experience with supporting laboratory developed tests (LDTs) under CAP/CLIA requirements
• Experience with automated liquid handling systems (e.g. Tecan/Hamilton)
• Experience in engineering design frameworks (e.g., Robust Design, Design For Six Sigma.)

• 100% paid medical, dental and vision premiums for employees and dependents
• 4 months paid parental leave
• Flexible Time Off
• 5 day winter break in December
• A meaningful mission and strong company culture

We are an equal opportunity employer and value 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.

This position is not eligible for agency partnership. Resumes and outreach from staffing representatives will be declined.