- Bachelor of Science
- Bachelor's degree
- Bachelor of Arts
- Quality assurance
- Technical writing
- ISO 13485
- Software testing
Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people! Our team is driven to make a difference for the patients we serve. We are leading the transformation of the genetics industry, by making clinical-grade genetic information affordable and accessible to guide health decisions across all stages of life.
Do you enjoy software development and system controls? Do you have impeccable attention to detail? We are looking for a Software Quality Design Engineer that loves documentation to join our Product Design Quality team and be an integral part of ensuring compliance for IVD product software.
What you'll do:
Continuously evaluate compliance, validation efforts, and effectiveness of IVD product software projects.
Collaborate, via review and authoring of documents, with product and non-product software used to support product verification, manufacturing, process validation, clinical data collection/data management, and in the creation of software documentation to support validated software design, development, verification, and review by regulatory authorities.
Support product software risk assessment, cybersecurity design considerations, development of software user needs and requirements, validation test protocol authoring and execution, and software configuration management.
Assist with product software execution of validation supporting IT infrastructure such as MES, ERP, eQMS software, clinical data collection systems & analysis software, and clinical data storage. Working with internal IT, data management, and clinical teams to support validation of data integrity, security, audit readiness, privacy (HIPAA, GDPR, etc.), data retention, storage, and recovery.
Partner with functional department leads to identify product software gaps, improvements, and oversee the validation and software performance to ensure the software and processes meet quality requirements/standards.
Act as point person for product and non-product software audits when working with external business partners and regulatory authorities. Demonstrate accountability and a dedication to continuous improvement by resolving issues when assigned findings for closure.
What you bring:
Minimum B.A. or B.S. (preferable in engineering or other technical fields), or experience in lieu of a degree.
3+ years in software testing to support software used in a regulated industry, with 3+ years of experience in software quality assurance and/or software tool validation.
Proven experience in performing software risk assessment, software validation & testing. Good technical writing skills with hands-on experience authoring, peer-reviewing, and defending software documentation for non-product, test data infrastructure, and non-product tools.
Experience within the Medical Device industry (IVD preferable) and applicable standards knowledge for the following: 21 CFR Part 11, ISO 13485, ISO 14971, 62304, GAMP, GDPR, HIPAA, Cybersecurity
Ability to speak and defend software validation documentation to external auditing authorities.
Ability to interact and communicate effectively with multiple disciplines.
Ability to work independently and apply good problem-solving skills.
Ability to multitask and work within a fast-paced dynamic team environment.
Please apply even if you don't meet all of the "What you bring" requirements noted. It's rare that someone checks every single item, it's ok, we encourage you to apply anyways.
At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.
We truly believe a diverse workplace is crucial to our company's success and to better serve our diverse patients. Your input is especially valuable. We'd greatly appreciate it if you can take a quick moment to make your selection(s) below. Submissions will be anonymous.