Design Quality Engineer
Heidi HealthRemotely
cloud securitysamddesign controlsiso 13485iso 14971iec 62304secure software development lifecyclenotified body audits
Job Description
📋 Description
- Hybrid role supporting engineering with Legal & Regulatory affairs.
- Focus on implementing global medical device design and safety standards.
- Lead design control processes across the software lifecycle.
- Translate IEC/ISO standards into actionable engineering processes.
- Support audits and maintain technical documentation.
- Collaborate with engineers, product managers, and auditors.
🎯 Requirements
- SaMD experience in regulated healthtech is preferred.
- Knowledge of IEC 62304, ISO 14971, ISO 13485.
- Technical security domain understanding (cloud, access, network).
- Strong collaboration and communication skills.
- Bachelor’s degree or higher is a plus.
🎁 Benefits
- Private medical and dental cover with Bupa.
- Wellbeing support and stipends; learning budget; parental leave.
- Hybrid working with 3 days in the office.
- Flexible work-from-anywhere options and fertility support.