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Calyxo, Inc. · 9 hours ago

Principal Software Quality Engineer - Pleasanton, CA

Pleasanton, CA

Full-time

Hybrid

Lead/Staff

$185K/yr - $205K/yr

12+ years exp

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. They are seeking a skilled and detail-oriented Principal Software Quality Engineer to ensure that their medical device products meet the highest quality standards throughout the software development process, from concept to commercialization.

Health CareMedicalMedical DeviceWellness

No H1B

Responsibilities

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 Calyxo’s 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

Qualification

Software Quality EngineeringMedical Device IndustryISO 13485FDA QMSRRisk ManagementSDLC/CSVDesign VerificationValidationFMEA ToolsAccountability MindsetPresentation SkillsProblem-Solving SkillsDetail-OrientedCollaborative Attitude

Required

Bachelor's 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