Lead Software Engineer

vor 22 Stunden

Munich, Bayern, Deutschland Meet Life Sciences Vollzeit 90.000 € - 120.000 € pro Jahr

We are supporting a medical device company that is growing its software team and is seeking an experienced
Software Engineer with a background in regulated medical device development
.

This role is suited to engineers who have already worked in medical devices and understand the responsibilities that come with developing software for safety-critical products.

You will be responsible for designing, developing and maintaining software used in medical devices across the full product lifecycle. You will work closely with hardware, systems, quality and regulatory teams to ensure software is developed in line with global regulations and design control requirements.

Key responsibilities

  • Design, develop and maintain embedded and/or application software for medical device products
  • Work within a regulated development environment following design controls and documentation requirements
  • Produce technical documentation including requirements, design descriptions, risk analysis and verification reports
  • Support verification and validation activities including testing and code reviews
  • Contribute to risk management activities such as FMEA and hazard analysis
  • Collaborate with Quality and Regulatory teams to ensure compliance with applicable standards
  • Support audits and regulatory submissions where required

Requirements

  • Proven experience developing software for regulated medical devices
  • Experience working under IEC 62304 and ISO 13485 environments
  • Understanding of design controls, software lifecycle management and traceability
  • Strong programming experience in C, C++, C# and/or Python (depending on product focus)
  • Exposure to verification and validation in a regulated setting
  • Familiarity with risk management processes related to software
  • Experience supporting regulatory inspections or audits is highly desirable

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