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Brainlab

Medical software and hardware for surgeries

Senior Systems Engineer - Project Engineer for Systems Engineering

Biomedical Engineering & Medical DevicesConfirmed live in the last 24 hours
Full-timeWaldkirch, GermanyNo salary listedIn-person

About the Job

Requirements

  • A Master's degree in Physics, Medical Engineering, Electrical Engineering, Mechanical Engineering, or a related technical or scientific discipline is required.
  • Several years of experience in medical device development, systems engineering, or research and development are required.
  • A proven track record of leading complex medical device development projects across the full product lifecycle is required.
  • Strong expertise in requirements engineering, design control, verification and validation, and risk management is required.
  • A sound understanding of medical device regulations and standards, including MDR and FDA requirements, is required.
  • Strong analytical, technical, and problem-solving skills are required, along with the ability to work effectively in multidisciplinary teams.
  • Excellent communication, stakeholder management, and project leadership capabilities are required.
  • Fluency in English is required.

Responsibilities

  • Lead systems engineering activities throughout the medical device development lifecycle, from concept development to product launch and sustaining engineering.
  • Define, analyze, and maintain system requirements while ensuring end-to-end traceability through design, verification, and validation.
  • Drive cross-functional collaboration between engineering, quality, regulatory, clinical, and manufacturing stakeholders.
  • Evaluate technical concepts, system architectures, and design solutions to ensure product performance, reliability, and patient safety.
  • Coordinate risk management, design reviews, verification and validation activities, and technical assessments.
  • Support regulatory submissions and compliance activities in accordance with MDR, FDA, and other applicable regulatory requirements.
  • Manage technical risks, drive problem-solving activities, and ensure successful project execution with respect to scope, timeline, and quality objectives.
  • Serve as a technical expert and mentor within interdisciplinary development teams.

Desired Qualifications

  • German language skills are an advantage.
  • Experience with FDA submissions, clinical evaluation, usability engineering, human factors engineering, electrical or electromechanical systems, and technical leadership within cross-functional development teams is preferred.
  • An interest in intraoperative neuromonitoring, neurosurgery and spine surgery, thyroid and ENT surgery, neurophysiological monitoring, signal acquisition, and measurement systems is preferred.

About the Company

Brainlab

Medical software and hardware for surgeries

Brainlab is a medical technology company that creates software and hardware to improve surgeries, radiosurgery treatments, and operating room efficiency. It serves hospitals and clinics by providing digital tools that enhance surgical precision and patient outcomes. The core products include image-guided navigation, planning software, and connected hardware that work together to guide procedures. Revenue comes from selling software licenses, hardware devices, and ongoing subscription services that include updates and support. The company differentiates itself by offering integrated digital medical technologies that combine software and hardware for a seamless clinical workflow, backed by service agreements. Its goal is to help healthcare providers perform safer, more accurate procedures and run operating rooms more efficiently through data-driven tools and ongoing support.

Company size
1,001-5,000
Company stage
Early VC
Total funding
$7.3M
Headquarters
Munich, Germany
Founded
1989

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