(Advanced / Senior) Project Engineer for Systems Engineering

Brainlab; Waldkirch; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

30 vacation days

Flexible working hours

Team and company events

Internal fitness program

Training and continuing education

Job summary

Dr. Langer Medical GmbH, part of Brainlab, Waldkirch, Germany, seeks an experienced Lead Systems Engineer to drive medical device development from concept to launch and sustaining engineering.

You will define requirements, ensure traceability, coordinate cross-functional teams, manage risk, and support MDR/FDA submissions. The role offers a collaborative, international environment with training and career growth opportunities.

Qualifications

• Master's degree in a related technical field.
• Several years of experience in medical device development, systems engineering, or R&D.
• Proven track record leading complex medical device projects across full lifecycle.
• Strong expertise in requirements engineering, design control, verification & validation, and risk management.
• Solid understanding of MDR and FDA requirements.
• Fluent in English; German is an advantage.

Responsibilities

• 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.
• Drive cross-functional collaboration between engineering, quality, regulatory, clinical, and manufacturing stakeholders.
• Evaluate concepts and architectures to ensure performance, reliability, and patient safety.
• Coordinate risk management, design reviews, verification and validation, and technical assessments.
• Support regulatory submissions and compliance activities in line with MDR, FDA, and other requirements.
• Manage technical risks and ensure on-time project execution with quality objectives.
• Serve as a technical expert and mentor within interdisciplinary teams.

Skills

System engineering

Leadership

Requirements engineering

Design control

Risk management

Cross-functional collaboration

Analytical thinking

Communication

Education

Master's degree in Physics

Master's degree in Medical Engineering

Master's degree in Electrical Engineering

Master's degree in Mechanical Engineering

Job description

Company Description

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.

Job Description

• 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.

Qualifications

• 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

Additional Information

• A mutually-supportive, international team
• Meaningful work with a lasting impact on medical technology
• 30 vacation days, plus December 24th and December 31st
• Flexible working hours
• 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

Contact person: Elisabeth Karro