R&D Mechanical Design Engineer

Contract R&D Mechanical Design Engineer

Location: Eindhoven, Netherlands (Hybrid)
Contract Length: 12 Months Initial Contract

Overview

Our client is seeking an experienced R&D Engineer to support the development of next-generation medical devices within a highly regulated Med-Tech environment.

The successful contractor will work as part of a multidisciplinary product development team responsible for research, concept development, detailed design, prototype development, verification, validation, risk management, and design transfer activities. This position offers the opportunity to contribute directly to innovative medical technologies across disposables, surgical instruments, and electromechanical systems while ensuring compliance with European medical device standards and regulations.

Key Responsibilities

• Lead the design and development of new medical device products from concept through commercialisation.
• Conduct technical research, feasibility studies, and proof-of-concept evaluations for innovative product concepts.
• Apply concurrent engineering principles to support efficient product development and cross-functional collaboration.
• Design and develop medical device disposables, surgical instruments, and capital equipment.
• Produce 3D CAD models, engineering drawings, and technical specifications using Solid Works or similar CAD platforms.
• Develop and test prototypes to evaluate functionality and reliability.
• Conduct failure analysis investigations and implement design improvements based on technical findings.
• Perform material selection and specification activities considering bio-compatibility, performance, and manufacturing requirements.
• Perform tolerance stack-up analysis, stress analysis, and engineering calculations to support robust product design.
• Drive Design for Manufacture and Assembly activities to support high-volume manufacturing environments.
• Support mold validation activities and collaborate with suppliers during tooling development.
• Perform cost analysis and value engineering activities to optimise product performance and reduce manufacturing costs.
• Support packaging development, transportation validation, shock testing, and vibration testing activities.
• Conduct design verification and validation activities in accordance with approved protocols.
• Collaborate with R&D, Quality, Regulatory Affairs, Manufacturing, and Supplier Quality teams throughout the development life-cycle.
• Support risk management activities in accordance with ISO 14971.
• Generate design documentation in compliance with EU MDR 2017/745, ISO 13485, IEC 60601 (where applicable), and internal design control procedures.
• Support transfer of products from development into manufacturing and commercial production.
• Participate in design reviews, engineering change activities, and continuous improvement initiatives.

Required Experience

• Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, Product Design Engineering, or a similar discipline.
• 5+ years of R&D or product development experience within the Medical Device industry.
• Experience developing products through the complete product development life-cycle, from concept to commercialisation.
• Strong experience with medical device design, verification, validation, and design transfer activities.
• Experience with medical device disposables, surgical instruments, or electromechanical medical systems.
• Strong CAD experience (Solid-Works preferred).
• Experience performing DFMA assessments and supporting high-volume manufacturing environments.
• Knowledge of material selection, manufacturing processes, and tooling considerations.
• Experience conducting failure investigations, root cause analysis, and product improvement activities.
• Understanding of ISO 13485 Quality Management Systems and ISO 14971 Risk Management.
• Working knowledge of EU MDR 2017/745 and regulated product development processes.
• Experience with prototyping, engineering testing, and technical documentation.
• Strong communication and stakeholder management skills.

Preferred Experience

• Experience developing Class II or Class III medical devices.
• Experience with cardiovascular, structural heart, minimally invasive surgery, diagnostics, or orthopaedic devices.
• Injection moulding, polymer component, or disposable medical device experience.
• Experience with electromechanical systems and capital equipment development.
• FEA, tolerance analysis, and simulation experience.
• Packaging validation, transportation testing, shock testing, and vibration testing experience.
• Design transfer and manufacturing scale-up experience.
• Experience working within European medical device regulatory environments.
• Medical device technical documentation and Design History File experience.