Staff Quality Engineer, Design Quality - Pleasanton, CA

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.

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself.

We also offer a compensation plan as follows:

A competitive base salary of $165,000 - $195,000 and variable incentive plan

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

Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only