Remotely
risk managementsystems engineeringfmeaiso13485design controlsfda 21 cfr part 820iso14971dhf
Job Description
📋 Description
- Drive the implementation of holistic Systems Engineering principles within the Design Controls
- Define and manage user and stakeholder needs, use cases, product requirements, and applicable
- Lead system and use-related risk management activities, including risk planning and reporting
- Oversee and integrate third-party development activities and ensure alignment of Design Control and
- Collaborate with cross-functional teams to plan and coordinate testing activities, including sample
🎯 Requirements
- Bachelor’s degree in Engineering, Science, or a closely related discipline with 7+ years of
- Proven ability to provide technical leadership, ensuring system design and documentation comply
- Expertise in product development from concept to market release, with direct experience in
- Strong expertise in Systems Engineering principles: user needs, requirements, risk management
- Experience with DHF management and creating Design Control documents compliant with regulations.
- Excellent written and verbal communication in Englisch and German; willingness to travel
🎁 Benefits
- Diverse work environment with real impact
- Open corporate culture
- Attractive salary
- Intensive onboarding with a mentor
- Flexible work models for healthy work-life balance
- Corporate health management and social benefits
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