Staff Systems Engineer
Staff Systems Engineer
Posted on :
23-04-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
23-04-2025
Job Description
About Us
DELFI Diagnostics Inc. (DELFI Diagnostics) is developing nextgeneration bloodbased tests that are reliable accessible and deliver a new way to help detect cancer. Employing advanced machinelearning methods to wholegenome sequencing data the DELFI (DNA EvaLuation of Fragments for early Interception) platform is built to address the highestburden 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 telltale patterns and characteristics of cellfree DNA (cfDNA) fragments. FirstLook Lung for individuals eligible for lung cancer screening is DELFI Diagnostics first laboratorydeveloped 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 lowdose 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 lifechanging 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 highperforming people. Through teamwork we build collective intelligence. Each of us wins when those we serve and those who serve with uswin. We show up with empathy humility and integrity at every step of the journey.
DELFI has 12 designated inoffice 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 NGSbased diagnostics aimed at early cancer detection. This position works as part of an outstanding crossfunctional 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.
What youll do
- 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 tradeoff 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 nonconformance reports or corrective and preventive action reports
- Partner with crossfunctional 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 crossfunctional 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 820compliant technical documents
- Exemplify and champion design control and systems engineering values and techniques
What youll have accomplished 12 months from now
- Become an expert on DELFIs technology and processes
- Lead a crossfunctional 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
What youll bring to DELFI
- 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 13485compliant quality management systems
- Experience carrying out ISO 14971compliant risk management activities
- Experience with development projects intended to lead to USIVD 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 nontechnical 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 highthroughput 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.
Preferred
What we offer fulltime employees
- 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
$150000 $190000 a year
Total Compensation at DELFI is a combination of salary bonus equity and benefits. Actual compensation packages are based on a wide array of factors unique to each candidate including but not limited to skillset years & depth of experience certifications & relevant education geography.
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.
Required Experience:
Staff IC
Employment Type
Full-Time
Key Skills
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