Senior Engineer, Software Test in Fremont

Overview

The Senior Engineer, Software Test will conduct testing of software for a robotic surgical system. The role includes reviewing software requirements, designing, implementing and documenting new tests, updating existing tests, executing tests, documenting results, and assisting in the development of test automation and automation frameworks. The successful candidate will be knowledgeable of industry standards and regulations for medical device development. This position is based in the Fremont, CA office.

• Review requirements to ensure they are complete, accurate, nonconflicting and testable; develop tests to ensure coverage of requirements.
• Increase depth of testing to identify difficult-to-find bugs.
• Document test protocols following internal SOPs and industry guidance and standards.
• Update existing tests for correctness.
• Assist team lead with planning and estimating testing activities for large projects.
• Maintain the traceability matrix.
• Execute tests and document results for regulatory submissions.
• Assist in developing automated tests and frameworks.
• Mentor junior team members on test development, SOPs and work instructions.
• Help devise and enforce procedures for following internal SOPs and guidance documents.
• Propose improved procedures and processes to increase team efficiency.

• Not applicable

Required:

• BS in Computer Science or related field.
• 7 years of experience testing software with at least 3 years testing medical devices.
• Good knowledge of IEC 62304, ISO 14971, ISO 13485, and General Principles of Software.
• Validation - Final Guidance for Industry and FDA Staff.
• Ability to program in C++ or at least one scripting language.
• Experience using commercial test automation tools.
• Excellent communication and documentation skills.
• Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.

Preferred:

• MS in Computer Science or related field.
• 10 years of experience testing software with at least 5 years testing medical devices.
• Experience building test automation frameworks from scratch.
• Experience leading small teams of testers.
• Experience with Linux or QNX.

• Decisive
• Demonstrates leadership
• Dependable
• Communicates effectively
• Collaborative
• Produces high quality work

• Must be able to remain in a stationary position and operate office equipment for a prolonged period.
• Physical activities include constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs.
• Additional physical activities include positioning self to complete tasks and ascending/descending floors and/or ladders.
• Occasionally work around moving mechanical parts.
• Must be able to work a schedule commensurate with business operations, including work during weekends, holidays, and/or times outside of normal business hours.
• Must be able to travel as business necessitates (up to 5%).

Disclaimer: The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be possible to enable individuals with disabilities to perform the essential functions.

THINK Surgical, Inc. (“THINK”) is committed to hiring qualified candidates for approved positions in compliance with all applicable employment laws. THINK provides equal employment opportunity to all applicants and employees. Any qualified applicant or employee who requires an accommodation should contact Human Resources and request an accommodation. THINK also participates in E-Verify. Actual compensation offered will depend on factors including location, experience, education, skill level, and/or other business and organizational needs.