The Quality Engineer for software process supports compliance to IEC 62304, ISO 13485, and ISO 14971 to ensure full adherence to these standards, in addition to the FDA’s Quality System Regulation and software-related guidance. This position represents the Quality Assurance 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.
- Implements all software development process related SOPs, ensuring compliance to IEC 62304 and other applicable standards, regulations, and guidance.
- Oversees the computer system validation (CSV) of non-product computer applications and tools used for quality system implementation, product development and testing, manufacturing, and service.
- Participates in risk management activities, including Hazard Analyses and FMEAs, across the various software projects, ensuring compliance with ISO 14971.
- Maintains software portions of the Risk Management File.
- 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 modifies product design and process documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and conformance to product and quality system requirements.
- Reviews and provides feedback for product requirements, design specifications, test plans, test protocols, and test reports.
- Supports design verification and design validation testing, and test method assessment and validation activities.
- Participates in failure investigations to analyze product or process failures and to implement related corrective and preventive actions.
- Audits Design History Files (DHF), Risk Management Files (RMF), Usability Engineering Files (UEF), and Technical Files and works with cross-functional teams to resolve documentation issues.
- Oversees software design transfer process and deliverables.
- 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.
- Performs other duties as assigned.
- A minimum of a Bachelor’s degree in an engineering discipline and/or a minimum of 7 years of professional experience in a medical device product development and manufacturing environment is required.
- 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 to apply IEC 62304 to software design and development.
- Familiarity with test methods and standards for the design, verification, and validation of medical device products is required.
- Experience in reviewing test plans/strategies.
- Experience with 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.