Calyxo, Inc. · 2 days ago
Staff Quality Engineer, Design Quality - Pleasanton, CA
Pleasanton, CA
Full-time
Hybrid
Lead/Staff
$165K/yr - $195K/yr
10+ years expCalyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA, focused on improving kidney stone treatment. They are seeking a skilled Staff Quality Engineer to ensure that Class-II new products meet the highest quality standards throughout the development process, from concept to commercialization.
Health CareMedicalMedical DeviceWellness
Responsibilities
Ensure 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 Quality System, FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601, and relevant global regulations
Drive 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 control documentation in compliance with ISO 13485 and 21 CFR Part 820
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
Maintain accurate and up-to-date quality records, including test reports, validation reports, and risk management documentation. Prepare and present quality-related reports to management and project teams
Promote a structured software development process in compliance with IEC 62304, assuring that a state of control is maintained with robust software risk management
Support regulatory submissions (e.g., 510(k), CE Mark) by providing design assurance documentation and justifications
Support sterilization assessments as per ISO 11135 EO and ISO 11137 radiation requirements
Support biocompatibility assessments as per ISO 10993 requirements
Lead root cause investigations and corrective actions related to design-related issues
Mentor junior engineers and promote a culture of quality and continuous improvement
Stay current with evolving regulatory standards and industry best practices
Collaborate with R&D to achieve electrical safety and EMC certification
Partner with supplier quality team and new suppliers to ensure that components and materials meet specified quality standards. Participate in supplier qualification and audit processes as needed
Support complaints investigations, NCs and/or CAPA 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
Required
Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Systems Engineering or a related technical field
Minimum 10 to 12+ years of experience in quality engineering within the medical device industry, with strong record of being a vital part of NPD launch
Strong knowledge, applications, and subject matter expertise of ISO 13485, ISO 14971, IEC 62304 and FDA 21 CFR Part 820
Excellent presentation skills and proactive leading mindset. Effective communication, collaborative attitude, and strong accountability mindset
Detailed understanding of design controls, 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. Proficient in statistical tools applications such as Minitab, Jump etc
Detail-oriented, with a commitment to producing high-quality work and maintaining rigorous documentation
Work location: Pleasanton, CA
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
Hybrid 4 days/week onsite, 1 day remote
Preferred
Certifications such as ASQ CQE (Americal Society for Quality Certified Quality Engineer), ASQ CSQE (Certified Software Quality Engineer), Six Sigma Black Belt or similar are a plus
Benefits
Stock options – ownership and a stake in growing a mission-driven company
Employee benefits package that includes 401(k), healthcare insurance and paid time off
Company
Calyxo, Inc.
Calyxo, Inc.
201-500 employees
H1B Sponsorship
Calyxo, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Late StageTotal Funding
$125.44MKey Investors
Avidity Partners
2024-12-26Series Unknown· $28.28M
2023-12-12Series D· $50M
2022-07-06Series C· $32.7M
Leadership Team
Joseph Catanese
President & CEO
Doug Hughes
Chief Financial Officer
Recent News
2025-12-18
2025-10-21
Medical Product Outsourcing
2025-09-13
Company data provided by crunchbase