(Advanced / Senior) Project Engineer for Systems Engineering

Brainlab; Waldkirch; On-site; EUR 85,000 - 110,000; Full time

Benefits offered by this job

30 vacation days

Team events

Training and education opportunities

Internal fitness program

Top 100 innovator employer

Job summary

Brainlab, headquartered in Munich and with Dr. Langer Medical GmbH operations in Waldkirch, seeks an Advanced/Senior Project Engineer for Systems Engineering.

You will lead systems engineering across the medical device lifecycle, ensuring traceability, risk management, and regulatory compliance while mentoring cross-functional teams. The role requires a Master’s degree and several years of medical device experience, with strong English skills and a plus for German proficiency.

Qualifications

• Master's degree in Physics, Medical Engineering, Electrical or Mechanical Engineering or related field.
• Several years of experience in medical device development or systems engineering.
• Proven track record leading complex medical device projects across full lifecycle.
• Strong knowledge of MDR and FDA requirements; English fluency essential; German a plus.

Responsibilities

• Lead systems engineering activities from concept to product launch and sustaining engineering.
• Define, analyze, and maintain system requirements with end-to-end traceability.
• Coordinate cross-functional collaboration among engineering, quality, regulatory, clinical, and manufacturing teams.
• Evaluate architectures and design solutions for performance, reliability and patient safety.
• Coordinate risk management, design reviews, and verification/validation activities.
• Support regulatory submissions and compliance with MDR, FDA and other requirements.
• Mentor interdisciplinary development teams and act as technical expert.

Skills

Systems engineering

Cross-functional leadership

Regulatory knowledge

Stakeholder management

Technical leadership

Education

Master's degree

Job description

(Advanced / Senior) Project Engineer for Systems Engineering

• Full-time

• Dr. Langer Medical GmbH, based in Waldkirch, Germany, which has been part of Brainlab SE in Munich since 2022, has specialized in the development and marketing of highly innovative medical technology for intraoperative neuromonitoring and neurostimulation for more than 25 years. Our products are groundbreaking in design and handling and form the basis for our worldwide growth. It is therefore no coincidence that the products from Dr. Langer Medical as well as the company itself have been honored several times in the past with various prizes and awards.

• • 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.
• • Master’s degree in Physics, Medical Engineering, Electrical Engineering, Mechanical Engineering, or a related technical or scientific discipline.
  • Several years of experience in medical device development, systems engineering, or R&D.
  • Proven track record of leading complex medical device development projects across the full product lifecycle.
  • Strong expertise in requirements engineering, design control, verification & validation, and risk management.
  • Sound understanding of medical device regulations and standards, including MDR and FDA requirements.
  • Strong analytical, technical, and problem-solving skills combined with the ability to work effectively in multidisciplinary teams.
  • Excellent communication, stakeholder management, and project leadership capabilities.
  • Fluent in English; German language skills are an advantage.
  • Preferred Qualifications: Experience with FDA submissions, clinical evaluation, usability engineering, human factors engineering, electrical or electromechanical systems, and technical leadership within cross-functional development teams. The ideal candidate is passionate about innovative medical technologies and has a strong interest in: Intraoperative Neuromonitoring (IONM), Neurosurgery and Spine Surgery, Thyroid and ENT Surgery, Neurophysiological monitoring, signal acquisition, and measurement systems
• • A mutually-supportive, international team
  • Meaningful work with a lasting impact on medical technology
  • 30 vacation days, plus December 24th and December 31st
  • Regular team, and company events
  • Internal company fitness program
  • Comprehensive training and continuing education opportunities offered by Brainlab
  • TOP 100 innovator and employer of the future 2022