Senior Consultant for Medical Device Innovation
vor 4 Wochen
Join FSQ Functional Safety & Quality Experts GmbH in Enhancing Medical Technology
At FSQ Experts, we provide medical technology firms with precise and practical solutions to navigate challenges in quality management, regulatory compliance, and system engineering.
Our clients are at the forefront of developing cutting-edge medical devices influenced by significant trends such as robotics, artificial intelligence, and the Internet of Things. Through our dedicated support, we foster a systematic approach to managing complexity, ensuring the certification of safe medical devices while cultivating a robust culture of quality and safety within these organizations.
We are currently seeking a Senior Consultant for Medical Device Innovation (m/f/d) to join our expert team.
Key ResponsibilitiesYour Role in the FSQ Experts Team:
- Provide comprehensive consulting and engineering support throughout the entire product lifecycle of innovative and complex medical devices.
- Leverage your extensive knowledge of product development methodologies, including both the V-model and agile frameworks.
- Assist clients in adhering to the IEC 60601-x series and IEC 62304 standards.
- Contribute to the application of general safety and performance requirements in line with global medical device regulations.
- Oversee and evaluate technical documentation to ensure compliance and quality.
- Empower client teams through your role as a technical advisor, process developer, facilitator, or coach.
Essential Experience and Skills:
- Proven experience as a technical consultant in the medical device sector.
- Extensive background in the technical development of medical device products.
- Strong understanding of hardware and software standards applicable to medical devices (e.g., IEC 60601-x series, IEC 62304).
- A risk-oriented mindset with knowledge of international regulatory requirements (e.g., MDR, FDA).
- Experience in environments compliant with ISO 13485 and ISO 9001 quality management systems.
Key Soft Skills:
- Pragmatic, organized, communicative, and service-oriented; eager to support and empower diverse clients.
- Curious and motivated to enhance FSQ's knowledge base in areas such as cybersecurity and artificial intelligence.
- Self-disciplined with excellent project and time management abilities; capable of managing multiple projects simultaneously.
- Fluent in both German and English (minimum level C1).
- Competitive salary and performance-based bonuses.
- Flexible remote work options and home office support.
- Access to modern working tools and equipment.
- Flexible working hours to accommodate personal needs.
- A culture of respect and collaboration among team members.
- An open and appreciative communication style.
- The opportunity to be part of a motivated and dynamic team.
- Engagement in a bright, agile, and modern company environment.
We look forward to your application
Join us in our mission to enhance the safety of technology for humanity.
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