Apply on Employer Site

Calyxo, Inc. · 3 weeks ago

Staff Quality Engineer, Design Quality - Pleasanton, CA

Pleasanton, CA

Full-time

Onsite

Lead/Staff

$165K/yr - $195K/yr

10+ years exp

Calyxo, Inc. is a medical device company focused on improving kidney stone treatment. They are seeking a skilled Staff Quality Engineer to ensure that Class-II new products meet quality standards throughout the development process, collaborating with various teams to integrate quality considerations into all phases of the product lifecycle.

Health CareMedicalMedical DeviceWellness

No H1B

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

Quality engineeringISO 13485FDA 21 CFR Part 820Risk managementDesign controlsFMEA toolsStatistical toolsPresentation skillsProblem-solving skillsCollaborative attitudeDetail-orientedMentoring

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

Legal authorization to work in the United States is required

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