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

• Bachelor's 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