Software Design Assurance & Quality Engineer
Ensures software compliance to regulatory requirements and applicable industry standards and guidances for software development, maintenance verification and validation (V&V) processes associated with medical device embedded software. This individual will participate in code review, audit software requirements, architecture, risk, design and test documentation against established software processes and work standards, and assess the risk of software anomalies.
Principle Responsibilities: (essential job duties and responsibilities)
- Work with software/ firmware designers and developers at all stages of development to assure conformance to software engineering procedures including software risk management.
- Review and approve software development documents, software V&V documents, and quality system procedures for medical device software.
- Audit software test procedures (including automated testing) and review software test results, pass/fail criteria and ensure bilateral traceability
- Perform software processes and documentation gap assessments against regulatory requirements, standards, industry guidance, quality system procedures, work instructions, templates, and project development plans.
- Facilitate discussions with Software Developers to triage and resolve anomalies identified during testing.
- Facilitate the use of current Software Quality techniques. Ensure compliance of new products to internal process requirements, industry standards (e.g. ISO, IEEE, IEC), and regulatory agency requirements.
- Participate in design and code review meetings relating to embedded systems.
- Manage product documentation through the Change Order and Release process.
- Contribute to system level hazard analysis and generate test guidelines for software products and/or the tools used in software development.
- Immediately elevate to management any major problem with device software that could affect safety, data security, customer usability or system adherence to process requirements.
- Support the supplier audit process, as applicable, as a subject matter expert in the auditing of embedded systems/product software providers
- Execute process improvement projects, as required
- Participate in any and all reasonable work activities as may be deemed suitable and assigned by management.
- Conform to, support and enforce all Company policies and procedures.
- Perform other duties/responsibilities as assigned by management
Skills and Experiences:
- Experience in medical device industry, designing, developing, debugging of embedded systems & executing of test plans and analyzing & reporting test results
- Working knowledge of FDA and IEC 62304 requirements for medical device software
- Experience in submitting Major Level of Concern software to FDA
- Working knowledge of C, C++, and LabVIEW
- Excellent verbal and written communication skills
- Strong problem-solving ability
- Exceptional attention to detail
- Ability to effectively manage multiple simultaneous tasks and priorities
- Proven track record of good time management, prioritizing tasks, and estimating quality activities.
- Demonstrated grasp of debugging and reviewing log captures.
- Ability to work on parallel product releases, with multiple project teams.
- Strong desire to learn and share information with others.
- Ability to deal effectively with all employees and external business contacts while conveying a positive, service oriented attitude.
- Ability to maintain confidentiality and discretion in business relationships and exercise sound business judgment.
- Bachelor’s degree with 3-5 yrs of experience of software quality or
- Master’s degree with 1-3 yrs of experience of software quality
- Bachelor’s and/or Master’s degree in Computer Science, Electrical Engineering, or similar degree
- Experience in regulated design environments, specifically medical device development, FDA or ISO registered work experience.
- Experience with IEC 60601 Certifications; 62304 Software standard
- Certification in Software Quality (SQA)
- Worked on software for products with a moderate or expected level of concern.