Senior Technical Consultant

vor 3 Wochen

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

At FSQ Functional Safety & Quality Experts GmbH, we are looking for a talented Technical Senior Consultant to join our team of experts.

The ideal candidate will have relevant experience in the role of technical consultant and a strong background in the technical development of medical device products.

Key responsibilities include:

  • Supporting the development of innovative and complex medical devices through consulting and engineering throughout the entire product lifecycle.
  • Utilizing in-depth knowledge of product development in both the V-model and agile frameworks.
  • Ensuring customer compliance with standards such as the IEC 60601-x series and IEC 62304.
  • Contributing to the implementation of general safety and performance requirements in accordance with global medical device regulations.
  • Coordinating and reviewing technical documentation.
  • Empowering customer teams through technical advisory, process development, facilitation, or coaching activities.

Requirements include:

  • Relevant experience as a technical consultant.
  • Many years of involvement in the technical development of medical device products.
  • Strong knowledge of HW and SW standards for medical devices, such as the IEC 60601-x series and IEC 62304.
  • A risk-oriented mindset and prior knowledge of regulatory requirements worldwide, including MDR and FDA.
  • Familiarity with working environments compliant with ISO 13485 and ISO 9001 quality management systems.

Additionally, the ideal candidate will possess:

  • Pragmatic, structured, communicative, and service-oriented skills, with a willingness to support and empower different types of customers.
  • Curiosity and a willingness to contribute to expanding FSQ's knowledge base in areas such as cybersecurity and artificial intelligence.
  • Self-organization, excellent project and time management skills, and the ability to support different projects in parallel.
  • Business fluency in German and English, with a minimum level of C1.

We offer a competitive salary and performance-based bonus, remote work and home office furnishings, modern working equipment, flexible working hours, and a respectful and open work environment.

If you are a motivated and talented individual looking to make a difference in the field of medical technology, we encourage you to apply for this exciting opportunity.

We look forward to receiving your application, including your CV and a motivation letter, and learning more about your qualifications and experience.

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