3 дня назад
R&D Software Design Control Specialist (Medical Devices)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
R&D Software Design Control Specialist (Medical Devices) (Pathology Software): Driving design control, requirements, risk management, and documentation for software used in pathology staining instruments for cancer diagnostics with an accent on regulatory compliance, product development, and sustaining engineering. Focus on converting user needs into requirements and user stories, conducting software and cybersecurity risk assessments, and coordinating verification and validation for regulated medical device software.
Location: Glostrup, Denmark (Copenhagen), with partial remote work available up to two days per week.
Company
develops pathology staining instruments and software for cancer diagnostics within its Clinical Diagnostics Division.
What you will do
- Execute software design control activities in accordance with the Quality Management System.
- Support software improvement, innovation, new product introduction, and sustaining projects.
- Ensure pathology software products comply with applicable regulatory requirements.
- Contribute to product design history files and other required documentation.
- Convert user needs into product requirements and user stories.
- Conduct software and cybersecurity risk assessments and collaborate on design verification and validation.
Requirements
- Engineering university degree in IT, computer science, software engineering, or a life science field.
- Background in software product development and sustaining or maintenance activities.
- Experience with design control, requirements engineering, design verification, change control, product risk management, defect management, and documentation for medical devices or IVDs.
- Experience working in a regulated environment such as medical devices or pharmaceuticals.
- Excellent written and verbal English communication skills.
- Ability to coordinate activities with cross-functional stakeholders and work systematically under changing priorities.
Nice to have
- Knowledge of IEC 62304 and ISO 14971.
- Experience with Agile software development.
Culture & Benefits
- International organization with a dynamic working environment.
- Career development opportunities.
- Company pension scheme and individual bonus plan.
- Private healthcare, medical insurance, and life insurance.
- Occasional travel and daytime work schedule.
Hiring process
- Applications are reviewed continuously.
- Applicants should submit a CV and cover letter through the recruitment system.
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