Software Design Assurance Engineer

Responsibilities

● Act as the primary Quality reviewer on software verification and validation (V&V) documents
for accuracy, clarity, consistency, completeness and compliance to applicable regulations
and industry standards. Documents may include protocols, reports (unit tests to system
validation), requirement specifications, development specifications, etc.
● Provide strategic and content recommendations for software verification and validation
protocols and reports – testing to requirements, equipment qualifications, tool qualifications,
etc. support V&V activities by providing insight on techniques, testing methodologies, etc.
● Identifies and escalates opportunities for streamlining existing test procedures and quality
processes
● Develop and update SOPs and Work Instructions in compliance with Cytovale’s QMS and
other regulatory standards
● Investigate non-conformities and implement corrective and preventive actions in coordination
with relevant cross-functional teams
● Lead and participate in product risk assessments
● Support transfer of product software and internal tools to manufacturing
● Other relevant duties and responsibilities as assigned

Qualifications

● Bachelors Degree in relevant science or engineering discipline (e.g., bioinformatics,
computer science, biomedical engineering) is strongly preferred
-Other educational backgrounds may be considered with relevant industry experience
● 4+ years of experience with product development in a regulated environment (e.g., medical
devices, pharmaceuticals, aerospace, semiconductors). Ideal candidate will have experience
with medical device and/or pharmaceutical development.
● Significant experience with evaluating product test strategy development and test case
design
● Demonstrated abilities with root cause analysis techniques (5 Why, Ishikawa / fishbone
diagrams, and similar)
● Demonstrated abilities with risk management techniques (FMEA, fault tree analysis, and
similar)
● Knowledge of 21 CFR 820.30, ISO 13485, ISO 14971, IEC 62304, GAMP 5, ANSI/CAN/UL
2900-1, ANSI/NEMA HN 1, ANSI/AAMI/ISO 80001 strongly preferred
● Familiarity with Python, JavaScript, and C/C++ preferred
● Familiarity with Linux preferred

Requirements

● This position will be based in the San Francisco Bay Area
● Ability to work in the United States
● Role is 2-3 days / week onsite to support software development and testing efforts,
possibility of remote work dependent on project objectives. Fully remote work available for
exceptional candidates.
● Up to 10% domestic travel

Additional Details

● The compensation plan includes a generous base salary, a yearly cash bonus based on
corporate and individual goal attainment, and an equity stake in the organization.
● Cytovale has a mandatory COVID-19 vaccination policy.

Who you are

● Fast learner with a “can-do” attitude and an ability to work independently
● Desire to work in a high velocity startup where collaboration is prized
● Excellent communicator, detail-oriented, and an avid GDP practitioner
● Able to influence without direct authority