Aktuelle Jobs im Zusammenhang mit Technical Lead for Medical Device Innovation - Munich, Bayern - FSQ Functional Safety & Quality Experts GmbH


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Technical Lead for Medical Device Innovation

vor 2 Monaten


Munich, Bayern, Deutschland FSQ Functional Safety & Quality Experts GmbH Vollzeit
About FSQ Functional Safety & Quality Experts GmbH

We are a leading provider of functional safety and quality expertise for medical device manufacturers. Our team of experts helps companies overcome complex challenges and achieve compliance with global regulations.

Job Summary

We are seeking a highly skilled Technical Senior Consultant to join our team. As a Technical Senior Consultant, you will play a key role in supporting the development of innovative medical devices, ensuring compliance with regulatory requirements, and providing technical expertise to our clients.

Key Responsibilities
  • Support the development of complex medical devices through consulting and engineering services
  • Apply in-depth knowledge of product development in V-model and agile frameworks
  • Ensure compliance with IEC 60601-x series and IEC 62304 standards
  • Contribute to the implementation of general safety and performance requirements in accordance with global medical device regulations
  • Coordinate and review technical documentation
  • Empower client teams through technical advisory, process development, facilitation, or coaching services
Requirements
  • Relevant experience in technical consulting
  • Many years of involvement in medical device product development
  • Excellent knowledge of HW and SW standards for medical devices
  • Risk-oriented mindset and prior knowledge of regulatory requirements worldwide
  • Familiarity with ISO 13485 and ISO 9001 quality management systems
Preferred Qualifications
  • Pragmatic, structured, communicative, and service-oriented approach
  • Curiosity and willingness to contribute to expanding FSQ's knowledge base in areas such as cybersecurity and artificial intelligence
  • Self-organized with excellent project and time management skills
  • Business fluent in German and English (at least level C1)
What We Offer
  • Competitive salaries and performance-based bonuses
  • Remote work and home office furnishings
  • Modern working equipment
  • Flexible working hours
  • A respectful and appreciative work environment
  • A motivated and agile team