Expert Technical Consultant

vor 2 Monaten

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

Join FSQ Experts in Enhancing Medical Technology

At FSQ Experts GmbH, we provide medical technology firms with precise and practical solutions to navigate challenges in quality management, regulatory compliance, and system engineering.

Our clientele develops cutting-edge medical devices influenced by significant trends such as robotics, artificial intelligence, and the Internet of Things. Through our practical assistance, we advocate for a systematic methodology to manage complexity effectively. We play a crucial role in certifying safe medical devices while fostering and enhancing a culture of quality and safety within these organizations.

We are seeking a Senior Technical Consultant - Medical Devices (m/f/d) to join our expert team.

Key Responsibilities

What will your role entail at FSQ Experts?

  • Support the design and development of innovative and intricate medical devices through consulting and engineering across the entire product lifecycle.
  • Leverage your extensive knowledge of product development methodologies, including the V-model and agile frameworks.
  • Assist clients in adhering to the IEC 60601-x series and IEC 62304 standards.
  • Facilitate the implementation of general safety and performance requirements in line with global medical device regulations.
  • Oversee and evaluate technical documentation.
  • Empower client teams through your expertise as a technical advisor, process developer, facilitator, or coach.
Qualifications

Essential Skills and Experience:

  • Proven experience as a technical consultant.
  • Extensive background in the technical development of medical device products.
  • Strong understanding of hardware and software standards for medical devices (e.g., IEC 60601-x series, IEC 62304).
  • A risk-oriented mindset with knowledge of global regulatory requirements (e.g., MDR, FDA).
  • Experience in environments compliant with ISO 13485 and ISO 9001 quality management systems.

Desired Soft Skills:

  • Pragmatic, organized, communicative, and service-oriented; eager to support and empower diverse clients.
  • Inquisitive and willing to contribute to expanding FSQ's knowledge in areas like cybersecurity and artificial intelligence.
  • Self-motivated with excellent project and time management abilities; capable of managing multiple projects simultaneously.
  • Fluent in both German and English (minimum level C1).
What We Offer
  • Competitive salary and performance-based bonuses.
  • Remote work options and home office support.
  • Modern work equipment.
  • Flexible working hours.
  • A respectful and collaborative work environment.
  • An open and appreciative communication culture.
  • Be part of a motivated team.
  • A dynamic, agile, and modern company atmosphere.

We look forward to your application

Please submit your CV and a motivation letter, including your earliest possible starting date and salary expectations. We are excited to learn more about you.

Join us in making technology safer for everyone.

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