Job
- Level
- Senior
- Location
- Waldkirch
- Working Model
- Onsite
- Job Field
- Application, Project
- Employment Type
- Full Time
- Contract Type
- Permanent employment
Job Summary
You will develop and manage complex systems throughout the entire lifecycle of medical devices, focusing on requirements, verification, validation, and coordinating interdisciplinary teams.
Your role in the team
- Leads 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.
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Our expectations of you
Education
- Master's degree in Physics, Medical Engineering, Electrical Engineering, Mechanical Engineering, or a related technical or scientific discipline.
Qualifications
- 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.
- 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.
Experience
- Several years of experience in medical device development, systems engineering, or R&D.
- 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.
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What we offer
- 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.
- Regelmäßige Team- und Firmenveranstaltungen.
- Internal company fitness program.
- Umfassende Schulungs- und Weiterbildungsangebote, die von Brainlab angeboten werden.
- TOP 100 Innovator and Employer of the Future 2022.
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Benefits
Health, Fitness & Fun
Work-Life-Integration
Topics You Will Work On
Job Locations
About Your Employer
Brainlab
Founded in Munich, Germany in 1989, Brainlab develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments.
Description
- Founding Year
- 1989
- Language
- English
- Company Type
- Established Company
- Working Model
- Hybrid, Onsite
- Industry
- Industry, Production
Senior Project Engineer Systems Engineering
- Location
- Waldkirch
- Working Model
- Onsite
- Diversity
- Open for all genders
