At MedAcuity, we work at the intersection of healthcare, technology and innovation in partnership with MedTech companies and innovators to develop software-driven medical devices, robotic technology, embedded systems, and computer vision solutions.
We seek a passionate and seasoned Software Quality Engineer who is interested in playing a key role in the cutting edge MedTech space. The Senior Quality Engineer will define test strategies and develop and coordinate verification and validation plans. The successful candidate will drive quality analysis and refine requirements for testability, gaps, and clarity.
Together, we’re pioneering the future of science by developing Software products and solutions that enable our partner teams to help save lives.
RESPONSIBILITIES and JOB DUTIES
- Contribute as a core team member representing the Quality Engineering functions in activities such as verification, validation planning, and risk analysis.
- Contribute to process validation, design verification, and design validation. Provide input regarding appropriate statistical methods, test methodologies, test facilities, and test equipment.
- Contribute to validation of software and/or production tools.
- Develop and maintain Quality Plans throughout the product life cycle beginning with project inception/initiation.
- Experience in developing and executing more sophisticated regression, acceptance, integration, performance, load, system-level, and reliability types of testing for all types of systems and platforms.
- Assist in the issue resolution and failure investigation process, as required.
- Conduct internal audits, as assigned.
- Maintain and comply with MedAcuity/client SOPs.
- Review procedures to ensure adequacy for software and device development to conform to business and Quality Management System requirements.
QUALIFICATIONS
- 8+ years of experience in quality testing.
- Expertise with defect tracking and metrics.
- Design, develop, and implement test automation frameworks such as Pytest, Robot, TestComplete, Squish.
- Strong technical writing skills, including development of test methods, protocols, and reports.
- Expertise with scripting languages such as Python.
- 5+ years of professional background with GIT revision control and software development methodologies.
- Understanding of Test Driven Development, Behavioral Driven Development, and data-driven test practices.
- Must possess a high sense of adaptability and initiative.
PREFERRED SKILLS
- Knowledge of requirements management software such as Helix, ALM, Jama, etc.
- Strong working knowledge of FDA QSRs, ISO 13485, IEC 62304, IEC 60601, ISO 14971 requirements.
- Experience with Agile and SCRUM methodologies.
- Prior experience in a consulting capacity.
EDUCATION
- Bachelor’s Degree in Computer Science or a related discipline OR equivalent years of experience in a comparable role.
Applicants for employment at MedAcuity, LLC are considered without regard to race, color, religion, sex, sexual orientation, gender-related identity/appearance, pregnancy, age, genetic information, national origin, status as a Vietnam Era or disabled veteran or membership in the uniformed services, physical or mental disability, or any other legally-protected classification.
MedAcuity is an equal opportunity employer.
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