Principal Software Quality Assurance Engineer, New Product Development (Fully Remote)

The Principal Software Quality Assurance Engineer is a fantastic opportunity to join the Software Quality group at Edwards Lifesciences in applying knowledge of software quality engineering to assess risk and compliance issues.

Edwards Lifesciences focuses on advancing technologies and improve the quality and efficiency of care. With over 40 years of technological advances, Edwards continues to evolve to less-invasive, and non-invasive devices; refine hemodynamic monitoring platforms; and provides evidence-based programs to enable proactive clinical decisions for surgical, anesthesia and critical care clinicians.

Key Responsibilities:

• Investigate complex product / non-product software quality and compliance issues (e.g., CAPAs, non-conformances, audit observations, software deviations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations, and develop reports.
• Develop software documentation for product or non-product software validation deliverables utilizing engineering knowledge
• Support internal and external audits
• Collaborate with stakeholders on the process improvements for product software
• Train, coach, and guide lower level employees on routine procedures and processes
• Other Incidental duties
• Assess Risk Management activities including authoring of Software Hazard Analysis for complex projects in partnership with cross-functional teams and provide recommendations for improvements
• Run the software change control group for New Product Development projects
• Perform DHF (Design History File) audits

Minimum Required Qualifications:

• Experience working within Software Quality, Software Development, or V&V (Verification and Validation)
• Bachelor's degree in Engineering, Computer Engineering, Computer Science or Scientific related fields with 6 years of relevant experience; OR Master's degree in same disciplines with 5 years of relevant experience
• Software Risk Management
• Requirements Management

Preferred Qualifications:

• Previous or current experience with SiMD (Software in a Medical Device)
• Experience or in-depth knowledge with Cybersecurity
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Software Development Lifecycle related to Software Quality Engineering (e.g., CQE body of knowledge) for product and non-product software
• Medical Device industry experience
• Knowledge of IEC 62304, ISO 13485, ISO 14971, and 21 CFR Part 11
• Proven experience with software development & testing; and utilizing testing tools such as: PTC, DOORS, V&V, JIRA, ADO, or similar tools

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $106,000 to $151,000(highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.