Job Summary
The consultant is responsible for crafting and implementing software testing strategies, which encompass test automation and verification processes specifically for medical device software. This role involves working alongside interdisciplinary teams to guarantee adherence to safety, regulatory, and design control standards.
Responsibilities
- Develop and implement comprehensive software testing strategies.
- Manage test automation and verification procedures for medical device software.
- Collaborate with various teams to meet compliance with safety and regulatory standards.
- Ensure adherence to design control requirements throughout the testing process.
Qualifications
- Bachelor’s degree in a technical discipline.
- Proven experience in software quality assurance and test automation in a regulated setting.
- Knowledge of medical device standards, specifically IEC 62304 and ISO 14971.
Element Science provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
