We are partnering with an established, internationally medical device manufacturer with a strong engineering culture and a collaborative working environment. The organisation combines structured processes with short decision-making paths and places high value on technical excellence, ownership and cross-functional teamwork.
This role offers the opportunity to contribute to technically demanding implantable systems within a regulated environment, working across the full product development lifecycle.
Key Responsibilities:
Product Development
End-to-end design and development of surgical instruments and implantable devices, from early concept generation through to clinical application.
Translation of clinical and user requirements into robust engineering solutions in compliance with regulatory frameworks.
Technical Design & Engineering
Creation of 3D CAD models and detailed technical drawings.
Development and evaluation of prototypes.
Execution of tolerance stack-ups, risk analyses (e.g. ISO and design optimisations.
Innovation & Problem Solving
Application of structured innovation methodologies and rapid prototyping techniques.
Systematic evaluation of design concepts with focus on functionality, manufacturability and usability.
Verification & Validation
Planning, coordination and documentation of design verification and validation activities.
Close collaboration with Quality and Regulatory functions to ensure compliance with MDR / FDA requirements.
Technical Documentation
Preparation and maintenance of development documentation including:
Risk management files
Design specifications
Test protocols and reports
Design history documentation
Candidate Profile:
Education & Experience
Degree in Mechanical Engineering, Medical Engineering or comparable technical discipline (BSc / MSc).
4+ experience in the development of regulated medical devices.
Demonstrated experience working within structured design control environments.
Technical Expertise
Advanced proficiency in 3D CAD systems (any major platform).
Design control processes
Verification & validation methodologies
Regulatory submission documentation (CE / FDA environments)
Experience preparing technical reports for regulatory approval.
Personal Competencies
Innovative, solution-oriented mindset with strong technical curiosity.
Ability to translate clinical or user feedback into practical engineering solutions.
Comfortable working in cross-functional, multidisciplinary project teams.
Professional-level German and/or English language skills.