Software Verification Engineer
Category: IT- Development
Contract To Hire
Position Title: Software Design Verification Engineer
Location: San Diego (Poway)
Summary/Objective: This position represents the R&D Software Design Verification function on product development teams from early design stages through product implementation to manufacturing, ensuring that all products comply with internal, customer, and regulatory requirements. Additionally, this position plays an active role in providing best-in-class quality engineering practices by focusing on executing tasks in an efficient and effective manner.
- Medical device experience
Essential Duties and Responsibilities
- Adheres to all software development process related SOPs, ensuring compliance to IEC 62304 and other applicable standards, regulations, and guidance.
- Performs design verification and design validation testing, and test method assessment and validation activities.
- Creates and conducts Intended Use Validations (IUV) of non-product computer applications and tools used for quality system implementation, product development and testing, manufacturing, and service.
- Participates in Design Reviews and the software defect review and evaluation process.
- Reviews all software development deliverables for compliance to applicable SOPs.
- Assists the Program Manager with the overall software project documentation plan to assign and track the various deliverables.
- Reviews and provides feedback for product requirements, design specifications, test plans, test protocols, and test reports.
- Participates in failure investigations to analyze product or process failures and to implement related corrective and preventive actions.
- Identifies and implements good quality engineering practices, including statistical methods and root cause analysis techniques.
- Supports continual product and process improvements.
- Reviews Usability and Human factors protocols and reports.
- Assists with compliance assessments of software to applicable cybersecurity rules and guidance.
- Maintain up-to-date training status on all quality system document training requirements.
Required Education and Experience
- BS degree in Computer Science or Engineering, or equivalent combination of relevant coursework and job-related experience.
Preferred Experience and Qualifications
- General design control and software-specific design control experience is essential.
- A working knowledge of the FDA Quality System Regulation, ISO 13485, ISO 14971, IEC 62304, FDA Guidance for General Principles of Software Validation; Final Guidance for Industry and FDA Staff and FDA Guidance for Content of Premarket Submissions for Software Contained in Medical Devices.
- Familiarity with IEC 82304, IEC 60601-1, and the EU Medical Device Regulation is a plus.
- Solid knowledge of and experience with non-product computer system validation (CSV) is required.
- Experience with Agile development methodology preferred.
- The candidate must know how IEC 62304 applies to software design. development and verification.
- Familiarity with test methods and standards for the design, verification, and validation of medical device products is required.
- Experience in reviewing test plans/strategies, CAPAs, root cause failure analysis.
- Experience with software projects, both pre-and-post-market.
- Excellent verbal and written communication skills (including presentation), especially technical writing, are required.
- The candidate must have the ability to work effectively on project teams.
- Experience in complex projects involving software and hardware integration is preferred.
- Good understanding of IEC 62366 Usability and Human Factors standard as it applies to software products is preferred.
- Solid working knowledge of cybersecurity rules and guidance is preferred.
- Substantial experience in Selenium Test Framework is strongly preferred.
- Substantial experience in Python and using Python based testing frameworks.
Interested in learning more? Reach out directly to Joe Hirlinger at firstname.lastname@example.org or 858-242-5611. Please don’t hesitate to visit our website www.sayvasolutions.com for more information, or follow our LinkedIn page for updates here: https://www.linkedin.com/company/sayva-solutions.
About Sayva: Sayva Solutions provides consulting, contract to hire, and direct hire recruiting to support project and full time placement needs. Our decades of combined industry experience has fostered a vast network and emphasis on efficiency, responsiveness, and quality results.Apply