Systems Engineer - Embedded and Hardware
- Hiring Organisation
- Get Staffed Online Recruitment
- Location
- Bedford, Bedfordshire, South East, United Kingdom
- Employment Type
- Permanent, Work From Home
- Salary
- £70,000
Partner with external suppliers to develop electronics, embedded firmware, and software for an IVD medical device, leading supplier governance across design controls, KPIs, risk management, schedules, budgets, quality, and regulatory compliance. Supplier Management and Deliverables : Author and manage supplier agreements (quality agreements, SOWs, acceptance criteria, configuration management … processes and deliver complete DHF/Technical Documentation regulatory expectations; align development to applicable standards. Risk, Submission and Audit Support: Lead and document risk management (ISO 14971), ensure readiness for UDI, labelling, post market surveillance, and change control, and support regulatory submissions and notified body audits by presenting clear ...