Leading software assurance activities throughout medical device software life cycle, including creating software quality assurance plan, determining software safety classification, software test readiness, software release readiness.
Responsible for ensuring traceability upwards to system level requirements and safety/security risk controls as well as downwards to software design, implementation and testing.
Being an active member of the software team during the whole software life cycle, with responsibility for physical and functional configuration audits, reviewing and approving software requirements, software architectural and detailed design, test procedures, test logs, test results, and providing insight to management regarding software project status and software quality metrics.
Ensuring compliance with applicable regulatory requirements and industry standards; performing gap assessments; immediately elevating to management any major problem with device software that could affect patient safety, cyber security, customer usability or system adherence to process requirements
Acting as a quality champion in software product development and testing teams
Supporting other software related processes such as CAPA process, and other quality related processes regarding cybersecurity risk management and software quality assurance.

Requirements

Master’s degree or higher in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering, Cyber Security, or Information Science and five (5) years of experience in software quality assurance in medical device, aerospace, or automotive industry OR Bachelor’s degree in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering, Cyber Security or Information Science and seven (7) years of experience in software quality assurance in medical device, aerospace, or automotive industry
Working knowledge of premarket and postmarket medical device regulations (FDA, EU and other agencies) and medical device related standards, such as ISO 13485, ISO 14971, IEC 62304, IEC 81001-5 series
Experience developing and testing software systems, SaMD, SiMD, and/or embedded software and creating appropriate documentation
Knowledge of Software Engineering best practices and working knowledge of C language preferred
Experience with embedded systems, IoT, Bluetooth, wi-fi and cellular technologies
Excellent verbal and written communication skills, strong problem-solving ability, and attention to detail
Ability to effectively manage multiple simultaneous tasks and priorities and perform under a dynamic environment with parallel product releases and multiple project teams
Ability to deal effectively with other employees and external business contacts while conveying a positive, service-oriented attitude.

Benefits

Health insurance
Dental & Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Voluntary Benefits
Paid Absences
Retirement Benefits

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

software quality assurancesoftware testingsoftware designsoftware developmentC languageembedded softwareSaMDSiMDdocumentation creationcybersecurity risk management

Soft skills

verbal communicationwritten communicationproblem-solvingattention to detailtask managementprioritizationinterpersonal skillsservice-oriented attitude