Blackhornvc
Senior Marketing Manager
Blackhornvc, Washington, District of Columbia, us, 20022
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.
Experience, qualification, and soft skills, have you got everything required to succeed in this opportunity Find out below.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 processesDevelop and update SOPs and Work Instructions in compliance with Cytovale’s QMS and other regulatory standardsInvestigate non-conformities and implement corrective and preventive actions in coordination with relevant cross-functional teamsLead and participate in product risk assessmentsSupport transfer of product software and internal tools to manufacturingOther relevant duties and responsibilities as assignedQualificationsBachelor'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 experience4+ 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 designDemonstrated 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 preferredFamiliarity with Python, JavaScript, and C/C++ preferredFamiliarity with Linux preferredRequirementsThis position will be based in the San Francisco Bay AreaAbility to work in the United StatesRole 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 travelAdditional DetailsThe 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 areFast learner with a “can-do” attitude and an ability to work independentlyDesire to work in a high velocity startup where collaboration is prizedExcellent communicator, detail-oriented, and an avid GDP practitionerAble to influence without direct authority
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Experience, qualification, and soft skills, have you got everything required to succeed in this opportunity Find out below.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 processesDevelop and update SOPs and Work Instructions in compliance with Cytovale’s QMS and other regulatory standardsInvestigate non-conformities and implement corrective and preventive actions in coordination with relevant cross-functional teamsLead and participate in product risk assessmentsSupport transfer of product software and internal tools to manufacturingOther relevant duties and responsibilities as assignedQualificationsBachelor'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 experience4+ 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 designDemonstrated 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 preferredFamiliarity with Python, JavaScript, and C/C++ preferredFamiliarity with Linux preferredRequirementsThis position will be based in the San Francisco Bay AreaAbility to work in the United StatesRole 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 travelAdditional DetailsThe 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 areFast learner with a “can-do” attitude and an ability to work independentlyDesire to work in a high velocity startup where collaboration is prizedExcellent communicator, detail-oriented, and an avid GDP practitionerAble to influence without direct authority
#J-18808-Ljbffr