Software Design Assurance Engineer
($140,000-160,000K/year)
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 the company'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
