(Advanced / Senior) Project Engineer for Systems Engineering

Brainlab; Deutschland; Presencial; EUR 90.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

30 vacation days

Team events

Internal fitness program

Training & education

Top 100 innovator award

Descripción de la vacante

Dr. Langer Medical GmbH, part of Brainlab SE in Munich since 2022, seeks an Advanced/Senior Project Engineer for Systems Engineering in Waldkirch, Germany.

You will lead systems engineering across the medical device lifecycle and coordinate cross-functional teams to ensure patient safety and product performance. The role requires a Master’s degree in a technical field and several years in medical device development, with strong requirements engineering, design control, and MDR/FDA knowledge.

Formación

• Master’s degree in Physics, Medical Engineering, Electrical or Mechanical Engineering; several years in medical device development.
• Proven track record of leading complex medical device projects across full product lifecycle.
• Strong knowledge of MDR and FDA regulatory requirements.
• Fluent in English; German language skills are an advantage.

Responsabilidades

• Lead systems engineering activities throughout the medical device development lifecycle, from concept to launch and sustaining engineering.
• Define, analyze, and maintain system requirements with end-to-end traceability across design, verification, and validation.
• Drive cross-functional collaboration between engineering, quality, regulatory, clinical, and manufacturing stakeholders.
• Evaluate concepts, architectures, and designs to ensure performance, reliability, and patient safety.
• Coordinate risk management, design reviews, verification and validation activities, and technical assessments.
• Support regulatory submissions and compliance activities in line with MDR, FDA, and other requirements.
• Manage technical risks and steer problem-solving to ensure on-time, high-quality execution.
• Serve as a technical expert and mentor within interdisciplinary teams.

Conocimientos

Systems engineering

Requirements engineering

Design control

Verification & validation

Risk management

Regulatory knowledge

Project leadership

Stakeholder management

English fluent

German advantageous

Educación

Master’s degree in Physics

Master’s degree in Medical Engineering

Master’s degree in Electrical Engineering

Master’s degree in Mechanical Engineering

Descripción del empleo

(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