Project Engineer (R&D and Product Support) – Cranial Navigation

Brainlab; München; Vor Ort; EUR 50.000 - 80.000; Vollzeit

Zusammenfassung

Ein innovatives Unternehmen im Bereich Medizintechnologie sucht einen engagierten Projektingenieur für Forschung und Entwicklung. In dieser Schlüsselrolle werden Sie Teil eines internationalen, interdisziplinären Teams, das an hochmodernen medizinischen Anwendungen für die Neurochirurgie arbeitet. Ihre Aufgaben umfassen die gesamte Entwicklung von medizinischen Geräten, von der Konzeptualisierung bis zur klinischen Bewertung. Sie haben die Möglichkeit, bedeutende Beiträge zu leisten, die den Alltag in Krankenhäusern weltweit verbessern. Wenn Sie leidenschaftlich an medizinischer Technologie interessiert sind und in einem dynamischen Umfeld arbeiten möchten, ist dies Ihre Chance!

Leistungen

30 Urlaubstage

Flexible Arbeitszeiten

Subventionierte Kantine

Fitnessprogramm

Regelmäßige Teamevents

Umfangreiche Weiterbildungsmöglichkeiten

Qualifikationen

• Abschluss in einem technischen oder ingenieurtechnischen Studiengang oder gleichwertige Berufserfahrung.
• Erfahrung in der Dokumentation und Freigabe von Medizinprodukten unter MDR und FDA von Vorteil.

Aufgaben

• Verantwortung für spezifische klinische und technische Bereiche in komplexen F&E-Projekten.
• Koordination und Durchführung von Verifizierungsaktivitäten für medizinische Geräte.

Kenntnisse

Problem-solving

Communication Skills

Documentation Quality

Agile Working Style

Ausbildung

Technical or Engineering Degree

Medical Technology

Mechanical Engineering

Computer Science

Tools

MDR Regulations

FDA Regulations

Jobbeschreibung

Project Engineer (R&D and Product Support) – Cranial Navigation

Pay Competitive

Employment type Full-Time

Job Description

Req#: REF1055J
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. Our key to success is our creative, talented and hard-working team, which consists of around 2000 dedicated and inspiring individuals in 25 locations worldwide. To succeed in reaching our targets, we are seeking committed colleagues who can stand behind our core values curious, authentic and useful:

As a Project Engineer in Brainlab’s R&D Division for Cranial Navigation, you will make an impact on the world’s leading medical applications for cranial surgery! You will be part of an international, multidisciplinary, highly skilled team which takes the responsibility for a wide range of applications and clinical procedures like cranial tumor resection, CMF, ENT, Microscope and Ultrasound navigation, based on either optical or electromagnetic tracking.

Your work includes the complete development cycle of medical devices, from the inception of new concepts over to their implementation up to the clinical assessment of the performance of the resulting device. Your contribution has an impact on daily work in hospitals around the world. We are currently looking for a highly motivated engineer with a focus on medical device R&D development tasks and product support activities.

R&D Activities Include:

• Responsibility for specific clinical and/or technical area in complex Research & Development projects for high end medical devices for Neurosurgery, CMF and ENT procedures.
• Core development tasks focus on software, and the interaction of the software with other devices and components, such as platforms, instruments, integrated microscopes or ultrasound devices.
• Requirements Engineering with Product Management, Surgeons and technical experts.
• Coordination and execution of verification activities (performance testing, functional testing of medical devices).
• Clinical evaluation & validation.
• Contribution to Usability Engineering Process.
• Creation of technical documentation according to international and company standards under MDR and FDA regulations.
• Communication with manufacturers.
• Communication with various internal teams (e.g. R&D teams for software, instruments and platforms, Quality Management, Quality Assurance, Usability & Design, Purchasing, Legal).
• Contribution to Change Management and Post Market Surveillance.

Product Support Tasks Include:

• Complaint handling activities including identify root causes, provide risk analysis data and facilitate the documentation of complaints. Serve as main contact interface between 2nd level support and R&D. Provide ideas and drive innovation to improve current products, provide sustainable input for continued engineering.
• Utilize your problem solving skills to suggest effective solutions to address identified product issues and enhance overall product performance.
• Work closely with cross functional teams, including Regulatory Affairs, Quality Assurance, Product Support and other R&D departments to implement actions to solve identified issues.
• Research and stay up to date with medical industry trends to drive continuous product improvement.
• Identify opportunities for product functionality and usability enhancement.

The allocation of tasks between product support and R&D development activities highly depends on the volume and nature of incoming complaints or challenges reported in the field, giving you the flexibility to adapt your focus and priorities accordingly, ensuring that the necessary attention is given to both areas.

Minimum Requirements:

• Graduate of a technical, engineering or scientific course of study (e.g. medical technology, mechanical engineering, electrical engineering, computer science, physics, informatics, mathematics) or equivalent working experience.
• Well-organized and clearly structured, agile working style.
• High documentation quality standards.
• Good communication skills.
• Eagerness to be part of an interdisciplinary team where your talent can grow.
• Fluent written and spoken English, German is a plus.
• Experience in documentation and releasing medical devices under MDR and FDA regulations is a plus - but not a pre-requisite.
• Clinical knowledge in areas of cranial procedures is a plus, especially with IGS products.

Benefits:

• 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.
• Parking garage and safe underground bike storage.
• Award-winning subsidized company restaurant and in-house cafes.
• Variety-rich fitness program in our ultra-modern 360m2 company gym.
• Regular after work, team, and company events.
• Comprehensive training and continuing education opportunities.

Ready to apply? We look forward to receiving your online application including your first available start date and desired salary.

Contact person: Géraldine Ferrer

About the Company

Brainlab is a privately held German medical technology company headquartered in Munich, Bavaria.