Senior R&D Engineer

Nobel Biocare; Herzogenrath; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Nobel Biocare in Germany is seeking a Senior R&D Engineer to lead design, development, verification, validation, and lifecycle management of medical devices.

You will provide technical leadership, ensure regulatory and quality compliance, and mentor junior engineers while collaborating across functions to drive innovation and reliable product performance.

Qualifikationen

• Bachelor's or Master's degree in Engineering or related field with relevant medical device focus.
• Strong knowledge of Design Controls, ISO 13485, ISO 14971, EU MDR and FDA.
• Fluent German and English, both written and spoken.
• Experience in cross-functional teams and project management.

Aufgaben

• Lead product development and technical decision-making.
• Perform design verification and validation.
• Manage risks and ensure regulatory compliance.
• Mentor junior engineers and interact with other departments.
• Prepare budgets and forecast accruals.
• Model values and promote the use of EBS tools.
• Assess field performance and reliability data.

Kenntnisse

Design Controls

Risk Management

Regulatory Compliance

Project Management

CAD

Verification & Validation

Systems Engineering

English (Fluent)

German (Fluent)

Mentoring

Ausbildung

Bachelor's degree in Engineering

Master's degree in Engineering

PhD in related field

Tools

CAD

QMS

EBS tools

Jobbeschreibung

The Senior R&D Engineer leads the design, development, verification, validation, and lifecycle management of medical devices, providing technical leadership and ensuring compliance with regulatory and quality requirements.

This Function Include The Following Relevant Tasks

• Lead product development
• Technical decision-making
• Design Verification and Validation
• Risk management
• Regulatory compliance
• Cross-functional collaboration
• Innovation activities
• Mentoring of junior engineers.
• Evaluate field performance and reliability data (Trend Reporting)
• Financial scope is defined in the budget
• Detailed responsibilities are defined in the QMS
• Modeling Circle values and promoting the use of EBS tools.
• Preparing budget and adjusting forecasts and accruals as needed

Job Requirements

• Bachelor's or Master's degree in Engineering or related field; typically multiple years of experience in medical device development. Completed PhD research project is a pre.
• In depth knowledge on standards and regulation including but not limited to:
• Design Controls, ISO 13485, ISO 14971, EU MDR, FDA regulations, V&V, systems engineering, CAD, risk management, etc.
• Project management competence and experience, ability to work in a team.
• Consequent and efficient, compliant and pragmatic
• Ability to work cross-functionally
• Agility to learn and to adapt individual and team performance to company standards and expectations
• Fluent in German and English, both in conversation as well as in writing
• Position requires a seasoned R&D professional with the potential for further personal development
• Relevant experience in Quality management and the regulated medical devices environment
• Experience in interacting with other departments, from cross-functional work and a basic understanding from all functions in the company

Operating company:Nobel Biocare