Staff Quality Engineer, Medical Devices – NPD Lead

Calyxo; Pleasanton (CA); Hybrid; USD 170,000 - 185,000; Full time

Benefits offered by this job

Stock options

401(k)

Healthcare insurance

Paid vacation

Job summary

Calyxo, Inc. in Pleasanton, CA, is seeking a Staff Quality Engineer to join the New Product Development team. You will ensure design controls, risk management, V&V, and regulatory compliance across Class‑II medical devices from concept to launch.

The role demands extensive quality engineering experience in the medical device industry, strong leadership, and collaboration with R&D, Regulatory, and Manufacturing. Hybrid work arrangement with onsite presence in Pleasanton.

Qualifications

• Bachelor’s degree in Engineering or related field required.
• Minimum 10–12+ years of quality engineering experience in the medical device industry.
• Strong knowledge of ISO 13485, ISO 14971, IEC 62304 and FDA 21 CFR Part 820.
• Experience with design controls, risk management, and process validation from concept to launch.
• Experience with V&V and software risk management.
• Ability to mentor junior engineers and lead quality initiatives.
• Hybrid work: 4 days onsite, 1 day remote; travel 5–10%.

Responsibilities

• Ensure design controls and risk management per ISO 13485, FDA 21 CFR Part 820, and IEC standards across NPD.
• Drive ISO 14971 risk management activities including FMEA and risk analyses.
• Maintain design control documentation per ISO 13485 and 21 CFR Part 820.
• Collaborate with R&D, Regulatory, PMO, and Manufacturing to ensure traceability and quality in all phases.
• Prepare and present quality reports to management.
• Promote a structured software development process per IEC 62304 and software risk management.
• Support regulatory submissions (510(k), CE Mark) with design assurance documents.
• Support sterilization and biocompatibility assessments.
• Lead root-cause investigations and CAPA for design-related issues.
• Mentor junior engineers and drive continuous improvement.
• Stay current with evolving regulatory standards.
• Collaborate on electrical safety and EMC certifications.
• Partner with supplier quality and audit processes.
• Conduct DHF audits at each phase.
• Review engineering docs and test protocols for compliance.
• Identify opportunities for process improvements.
• Lead initiatives to improve product quality and reduce costs.

Skills

Quality engineering

NPD launch

FMEA

Statistical tools

Design controls

Regulatory knowledge

Problem solving

Communication

Leadership

Documentation

Education

Bachelor’s degree in Engineering, Biomedical Engineering, Mechanical Engineering, Systems Engineering or a related technical field

ASQ CQE, ASQ CSQE, Six Sigma Black Belt or similar certifications

Tools

Minitab

JMP

Job description

Calyxo, Inc. in Pleasanton, CA, is seeking a Staff Quality Engineer to join the New Product Development team. You will ensure design controls, risk management, V&V, and regulatory compliance across Class‑II medical devices from concept to launch.

The role demands extensive quality engineering experience in the medical device industry, strong leadership, and collaboration with R&D, Regulatory, and Manufacturing. Hybrid work arrangement with onsite presence in Pleasanton.