Calyxo
Staff Quality Engineer, Design Quality - Pleasanton, CA
Pleasanton, CA · Staff+
Sponsorship not specifiedDetected 4 days ago
Project ManagementEMI/EMCFDA RegulatoryMedical DevicesRegulatory Affairs
About the role
- Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA.
- 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.
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.
- 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.
- 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.
- Collaborate with R&D to achieve electrical safety and EMC certification.
- Support sterilization assessments as per ISO 11135 EO and ISO 11137 radiation requirements.
- Support biocompatibility assessments as per ISO 10993 requirements.
Benefits
- Drive risk management activities per ISO 14971, including risk management plan, hazard analysis, FMEAs (design, software, user), risk-benefit analysis, and risk management report.
- 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.
Company info
- The company was founded in 2016 to address the profound need for improved kidney stone treatment.
- 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 listing is sourced directly from Calyxo's careers page and normalized into a canonical job model.