We are hiring a Senior Marketing Manager to support marketing efforts for the novel IntelliSep sepsis test. This will be a highly visible position with exposure to both executive leadership within the organization, additionally to key opinion leaders within the sepsis space.

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