PRINCIPAL RESPONSIBILITIES:

• Leads Verification Automation Architecture
• Leads the development and execution of system verification plans for medical devices, ensuring compliance with all relevant regulations.
• Designs and implements test strategies and methodologies for various system components and functionalities across the Software, Hardware, and Systems levels. Analyzes system requirements and translates them into test protocols.
• Defines, develops, and maintains automated test solutions using appropriate tools and languages (e.g., Test Frameworks).
• Guides the development of products and test automation at all levels of the software stack, including application development, DevOps, and release management. Guides the development and maintenance of CI/CD pipelines.
• Performs manual testing and analysis to identify and document potential issues and defects.
• Participates in risk assessments and failure mode analysis (FMEA) to identify and mitigate potential risks.
• Maintains accurate and complete documentation of all verification activities, including test plans, reports, and defect tracking.
• Comply with the company's Code of Ethics, the company's Quality System, and all company policies, rules, and housekeeping standards.

EDUCATION / EXPERIENCE REQUIREMENTS:

• Master's Degree in Computer Science or equivalent with appropriate experience (Computer Engineering, Electrical Engineering).
• 8+ years of verification development in senior development and lead roles, preferably in medical devices or regulated industry, with a proven track record of deployment in commercial products.
• Proven experience as a Team Leader, taking product ideas to market success.
• Experience in Agile, Azure DevOps, CI/CD, Source Code Management, Verification Automation, Scrum, and Software Life Cycle Development in a regulated environment.
• Experience with medical device regulatory standards such as 21 CFR Part 820, IEC 60601, IEC 62304, and ISO 13485, including experience with system risk, hazard analysis, and DFMEA.
• Deep commitment to understanding and solving problems for end users, with an ability to translate into test specifications.
• Conducts effective design reviews and demonstrates critical attention to detail.
• Excellent verbal and written English communication and presentation skills.
• Critical thinking and problem-solving skills, including identifying, recommending, and implementing solutions.
• Required to work cross-functionally within the organization and with external customers and vendors.
• Self-directed and proven skill to work independently and as part of a team.
• Results-oriented with strong analytical skills, exercises appropriate judgment, and makes decisions based on accurate and timely information.
• Possesses high integrity and dependability with a strong work ethic.
• Self-motivated to work efficiently in a team-oriented environment.
• Promotes and fosters a positive behavior and work environment.
  

Desired Skills and Experience

Agile, Azure DevOps, CI/CD, Source Code Management, Verification Automation, Scrum, Software Life Cycle Development, IEC 62304

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

To find out more about Real, please visit www.realstaffing.com