Job
- Level
- Senior
- Ort
- Waldkirch
- Arbeitsmodell
- Onsite
- Job Feld
- Application, Project
- Anstellung
- Vollzeit
- Vertragsart
- Unbefristetes Dienstverhältnis
Job Zusammenfassung
Du entwickelst und betreust komplexe Systeme während des gesamten Lebenszyklus medizinischer Geräte, kümmerst dich um Anforderungen, Verifikation und Validierung und koordinierst interdisziplinäre Teams.
Deine Rolle im Team
- 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.
Unsere Erwartungen an dich
Ausbildung
- Master's degree in Physics, Medical Engineering, Electrical Engineering, Mechanical Engineering, or a related technical or scientific discipline.
Qualifikationen
- 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.
Erfahrung
- 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.
Unser Angebot
- 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.
Benefits
Gesundheit, Fitness & Fun
Work-Life-Integration
Themen mit denen du dich im Job beschäftigst
Job Standorte
Das ist dein Arbeitgeber
Brainlab
Brainlab entwickelt Medizintechnik, um Patient:innen und Ärzt:innen auf der ganzen Welt den Zugang zu einer besseren medizinischen Versorgung zu erleichtern.
Description
- Gründungsjahr
- 1989
- Sprachen
- Englisch
- Unternehmenstyp
- Etablierte Firma
- Arbeitsmodell
- Hybrid, Onsite
- Branche
- Industrie, Produktion
Senior Project Engineer Systems Engineering
- Ort
- Waldkirch
- Arbeitsmodell
- Onsite
- Diversität
- Für alle Personen geeignet (m/w/d)
