Principal Software Quality Engineer Pleasanton, CA

Calyxo Inc. is a medical device company headquartered in Pleasanton California USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.

Are you ready to change the future of kidney stone treatment We are seeking high achievers who want to be part of a dynamic team working in a fun diverse atmosphere.

Summary:

We are seeking a skilled and detail-oriented Principal Software Quality Engineer to join our New Product Development (NPD) team. This role is responsible for ensuring that our medical device products meet the highest quality standards throughout the software development process from concept to commercialization. The ideal candidate will have experience in the medical device industry and a strong understanding of software quality engineering principles design and development project management and regulatory requirements. This role will focus on ensuring that software quality is embedded in the design development and manufacturing of new medical devices.

In This Role You Will:

• Ensure software design controls for new product development and improvement project activities including risk management design V&V product software validation design reviews tagging/tracing non-product tools validation test method validation and design transfer are in compliance with Calyxos Quality System FDA QMSR (formerly 21 CFR Part 820) ISO 13485 ISO 14971 IEC 62304 IEC 60601 and relevant global regulations.
• Promote a structured software development process in compliance with IEC 62304 assuring that a state of control is maintained with robust software risk management.
• Drive software risk management activities per ISO 14971 including risk management plan hazard analysis FMEAs (design software user) risk-benefit analysis and risk management report.
• Own and maintain design and development documentation in compliance with ISO 13485 and FDA QMSR (formerly 21 CFR Part 820).
• Define and track appropriate software quality metrics. Present Software QA dashboard to cross-functional management on a regular basis to highlight key software signals such as resolved defects open anomalies field complaints data related to software business urgencies open risks/mitigations milestones accomplishments etc.
• Provide timely support and reviews for key cybersecurity deliverables: SBOM Penetration Testing and STRIDE analysis. Ensure that Calyxo devices/systems fully comply with the latest cybersecurity regulations.
• Serve as the lead design quality authority for software (Medical device SaMD/SiMD embedded firmware digital health platforms AI/ML features non-product software) from concept through commercialization embedding risk-based design and development STRIDE threat modeling cybersecurity assurance and CSV/SDLC rigor across programs.
• Proactively drive procedural improvements involving best practices in software design and development and software tools management. Collaborate with Quality Systems and R&D to establish and monitor a formal list of all software tools used for Calyxo NPD Programs.
• Collaborate with R&D PMO Regulatory Affairs and Manufacturing to ensure robust design inputs outputs traceability and quality considerations are integrated into all phases of the product development lifecycle.
• Partner with R&D and IT team on key activities related to use and validation of non-product software platforms such as JAMA Jira Confluence etc.
• Maintain accurate and up-to-date quality records including software test reports software validation reports and software risk management documentation. Prepare and present quality-related reports to management and project teams.
• Support regulatory submissions (e.g. 510(k) CE Mark) by providing design assurance documentation and justifications.
• Lead root cause investigations and corrective actions related to design-related issues.
• Provide continuous guidance and leadership on the best practices of software quality to cross-functional teams.
• Partner with supplier quality team to qualify new software suppliers as applicable.
• Support complaint investigations NCs and/or CAPAs related to NPI complaints post-launch.
• Conduct DHF audits at each phase to ensure phase deliverables are complete.
• Review and approve engineering documentation test protocols and reports to ensure compliance and technical integrity.
• Identify opportunities for continuous improvement in product design and manufacturing processes. Lead or participate in initiatives to enhance product quality reduce costs and improve overall efficiency.

Who You Will Report To:

• Director Design Quality Assurance

Requirements:

• Bachelors Degree in Engineering Biomedical Engineering Software/Computer Science Systems Engineering Electronics Mechanical Engineering or related technical field.
• Minimum 12 years of experience in software quality within the medical device industry with a strong record of being a vital part of NPD launch.
• Hands-on application and leadership in SDLC/CSV traceability anomaly/defect management and audit readiness for SaMD/SiMD.
• Strong knowledge applications and subject matter expertise of ISO 13485 ISO 14971 IEC 62304 and FDA QMSR.
• Excellent presentation skills and a proactive leading mindset. Effective communication collaborative attitude and strong accountability mindset.
• Detailed understanding of new products design/development risk management and process validation in the context of medical device development from concept to feasibility to V&V to design transfer to launch.
• Experience with systems design verification and validation (V&V) activities including support for development of test protocols and reports.
• Hands-on experience working with FMEA tools (design software user).
• Excellent problem-solving skills with the ability to analyze complex technical issues and develop effective solutions.
• Detail-oriented with a commitment to producing high-quality work and maintaining rigorous documentation.
• Preferred but not required: Certifications such as ASQ CSQE (Certified Software Quality Engineer) Six Sigma Black Belt or similar are a plus.
• Work location: Pleasanton CA (hybrid 4 days/week onsite 1 day remote).
• Travel: 5-10% domestic travel may be required.
• Full time employment.
• Must be able to lift 10-15 pounds and sit for up to 8 hours/day.
• Compliance with relevant county state and Federal rules regarding vaccinations.

What We Offer:

At Calyxo you will be part of a knowledgeable high-achieving experienced and fun team. You will work in a diverse work environment with experienced proven leaders and have an opportunity to shape our company culture. You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself.

We also offer an attractive compensation package which includes:

• A competitive base salary range of $185000 - $205000 and variable incentive plan
• Stock options ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k) healthcare insurance and paid vacation

Calyxo is deeply committed to fostering an environment where diversity and inclusion are not onlyvalued but alsoprioritized. We believe a diverse and inclusive community empowers us to act courageously care deeply and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.

Calyxo is proud to be an equal opportunity employer seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race color religion gender gender identity or expression sexual orientation national origin genetics disability age veteran status or any other applicable legally protected characteristics

Legal authorization to work in the United States is compliance with federal law all persons hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Disclaimer:

At Calyxo we prioritize a transparent and structured interview process to ensure the best fit for both our candidates and our team. Please be aware of the following:

• Structured Interview Process: Our hiring process includes multiple stages of interviews where you will have the opportunity to communicate directly with Calyxo employees. This ensures that you gain a comprehensive understanding of the role and our company culture.
• Verification of Identity: We do not extend job offers without first meeting candidates either virtually or in person. This step is crucial to maintain the integrity of our hiring process and to ensure mutual alignment.
• Beware of Scams: Calyxo will never request sensitive personal information such as your full name address phone number or identification documents via email or online forms before an official interview. Calyxo representatives will always contact you using an email format of. If you receive a request for information from any other domain please contact us directly at to verify the legitimacy of the communication.

We appreciate your interest in joining Calyxo and look forward to getting to know you through our official channels.