Entity: Occam-Labs (Capstan Medical + Versa Vascular)

Reports to : Director of Quality

Workplace Type: Hybrid

About us:

Occam Labs is an engineering incubator targeting early-stage medical device design. We focus on cultivating cutting edge technology centered on patient value. Our team is highly collaborative and hands-on, takes pride in iterating quickly, and believes that the best ideas can come from anywhere or any person! We always have multiple programs in the pipeline, so as a small team, we tend to wear multiple hats on a daily basis.

Occam Labs is uniquely positioned in Santa Cruz, which we have chosen to be geographically close-to but intentionally separate from the greater SF Bay Area. This gives us access to the amazing technical talent of the bay area but in an environment that we feel is conducive to doing our best creative work. Our office is located in a repurposed warehouse space that used to be the Wrigley Gum factory, now the funky/diverse home to several bicycle companies, many art and architecture studios, a maker space, and several biotech startups. It is adjacent to large tracts of open space with bicycle trails straight from the office doors offering access to the hills and beaches of Wilder Ranch State Park for road/mountain bicycle riding, hiking, and surfing.

Currently, our active programs at Occam Labs target catheter-based, repair devices for diseases that affect the heart. These kinds of devices present patients with compelling, minimally invasive alternatives to traditional surgical methods. For most patients, this means less pain after surgery and being able to return to normal life much more quickly. For many older patients, reducing surgical trauma can make the difference between life and death. Our current strength is in micro-scale mechanical medical devices on the cutting edge of medicine but we are constantly evolving. The team has a collective background designing a wide variety of medical devices including cardiac devices, catheter-based devices, collapsible implants, surgical tools and robotic systems.

Description :

We are seeking a highly motivated and detail-oriented Software Quality Engineer (SQE) to join our growing team in the development of cutting-edge medical robotic systems. This role is pivotal in ensuring compliance with applicable regulatory standards and internal quality processes throughout the software development lifecycle. You will work closely with cross-functional teams to drive quality assurance initiatives across product and non-product software, with a focus on code review, validation, and documentation using modern DevOps tools such as GitLab.

Responsibilities Include :

Collaborate with R&D, Systems, and QA teams to ensure software for medical robotics systems meets regulatory and internal quality requirements (e.g., IEC 62304, ISO 13485, 21 CFR Part 820, 21 CFR Part 11). Conduct and document software code reviews, ensuring code quality, maintainability, and compliance with project standards. Oversee and perform non-product software validation activities, including risk assessments, validation planning, protocol development, testing, and final reports in accordance with FDA and ISO guidance. Develop and review software development and validation documentation, such as software requirements, design specifications, test protocols, and traceability matrices. Ensure proper use of configuration management tools (e.g., GitLab), including reviewing merge requests, managing branches, and ensuring traceability. Support audits and inspections by preparing documentation and providing subject matter expertise for software-related processes. Drive continuous improvement initiatives within software quality processes, SOPs, and tools. Review and assess software change controls and deviations. Collaborate with cybersecurity and risk management teams to ensure software quality considerations are integrated into broader risk processes. Provide training and guidance to development teams on quality standards and best practices. Qualifications : Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or related field. 3+ years of experience in software quality assurance, preferably in the medical device or regulated industry. Strong understanding of software development life cycle (SDLC) in regulated environments. Hands-on experience with code reviews, preferably using GitLab or similar version control platforms. Proven experience with non-product software validation and knowledge of FDA software guidance and GAMP5. Familiarity with medical device regulations and standards (e.g., IEC 62304, ISO 13485, ISO 14971, 21 CFR Part 11/820). Strong analytical, organizational, and documentation skills. Excellent communication skills and ability to work cross-functionally in a collaborative environment. Why join us: We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space that can make a meaningful impact for patients. We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family , as well as flex time off. We thrive in our work-hard, play-hard environment. Bring your bike or running shoes if you'd like or just be ready to enjoy a fun office outing. We enjoy time inside the office and out!

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, veteran status, and disability, or other legally protected status.