Quality Engineer, Design Quality

Overview

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.

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

This role will focus on ensuring that quality is embedded in the design, development, and manufacturing of new medical devices. The ideal candidate will have a strong background in quality engineering within the medical device industry, with experience supporting Class-II or Class-III product development lifecycle and software development, from concept through commercialization.

• 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.
• Collarborate with R&D to acheive 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.

• Director, Design Quality Assurance

• 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…