HealthCare Recruiters International
Staff Software Engineer- Surgical Robotics
HealthCare Recruiters International, Los Gatos, California, United States, 95032
We are seeking a highly motivated and detail-oriented
Senior/Staff Software Design & Quality Engineer
to join our growing team in the development of cutting-edge medical robotic systems. This role is pivotal in ensuring both design rigor and compliance with applicable regulatory standards and internal quality processes throughout the software development lifecycle. You will work closely with cross-functional teams to drive SW development initiatives with a focus on code review, validation, and documentation using modern DevOps tools such as GitLab.
Responsibilities include: Leverage your software development expertise to architect and implement continuous integration infrastructure to increase the rate of product development and decrease formal software verification time Lead software design verification testing activities in support of clinical submissions Conduct and document software code reviews, ensuring code quality, maintainability, and compliance with project standards 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, 14971) 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
Qualifications: Bachelors degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field 8+ years of software development life cycle (SDLC) for complex electromechanical systems, preferably in the medical device of other regulated industry Ability to do some coding in Python and C++ is preferred Knowledge of software development quality assurance, verification & validation processes 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
Senior/Staff Software Design & Quality Engineer
to join our growing team in the development of cutting-edge medical robotic systems. This role is pivotal in ensuring both design rigor and compliance with applicable regulatory standards and internal quality processes throughout the software development lifecycle. You will work closely with cross-functional teams to drive SW development initiatives with a focus on code review, validation, and documentation using modern DevOps tools such as GitLab.
Responsibilities include: Leverage your software development expertise to architect and implement continuous integration infrastructure to increase the rate of product development and decrease formal software verification time Lead software design verification testing activities in support of clinical submissions Conduct and document software code reviews, ensuring code quality, maintainability, and compliance with project standards 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, 14971) 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
Qualifications: Bachelors degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field 8+ years of software development life cycle (SDLC) for complex electromechanical systems, preferably in the medical device of other regulated industry Ability to do some coding in Python and C++ is preferred Knowledge of software development quality assurance, verification & validation processes 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