Medical Devices Design Engineer

Role and Responsibilities:

1.

Design and develop electromechanical medical devices, including mechanical subsystems, precision components, assemblies, and associated accessories from concept through production.

2.

Develop innovative product concepts, detailed 3D CAD models, assemblies, engineering drawings, tolerance analyses, bills of materials, material specifications, and technical documentation.

3.

Build, source, and evaluate prototypes through rapid prototyping, prototype tooling, and representative manufacturing processes; analyse prototype performance and use results to improve product design, reliability, usability, and manufacturability.

4.

Apply Design for Manufacturability (DFM) and Design for Assembly (DFA) principles to optimize component design, assembly processes, product quality, reliability, and cost.

5.

Perform engineering analyses, including design calculations, tolerance stack-up analysis, FEA and CFD, where applicable, to evaluate strength, fatigue, thermal performance, fluid flow, and durability.

6.

Lead design reviews, DFMEA, risk assessments, root-cause analysis, failure analysis, and corrective actions to identify and mitigate product, subsystem, component, interface, and manufacturing risks.

7.

Develop engineering test strategies, test fixtures, and reports to support prototype evaluation, design verification, reliability testing, usability activities, and product validation.

8.

Maintain design-control and product-lifecycle documentation, including requirements, design inputs and outputs, change-control records, Engineering Change Orders, and technical reports.

9.

Collaborate with Quality, Regulatory, Systems Engineering, Manufacturing, Supplier Quality, Clinical, Human Factors, Sourcing, and Project Management teams.

Education & Experience:

1.

Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or a related engineering discipline with 8+ years of experience in medical product design and development.

2.

Strong proficiency in parametric 3D CAD software, preferably Creo & SolidWorks with experience creating 3D models, detailed engineering drawings, assembly definitions, bills of materials, and production-ready design documentation.

3.

Practical experience applying DFM and DFA principles to precision machining, injection moulding, sheet metal, casting, forging, surface finishing, coatings, and joining methods.

4.

Knowledge of FDA requirements, European MDR expectations, ISO 13485, ISO 14971, and other applicable medical-device quality and regulatory practices.

5.

Strong communication, technical documentation, innovation, stakeholder-management, and cross-functional collaboration skills, with experience supporting NPI, manufacturing transfer, product design support, and the complete product lifecycle;

6.

Orthopaedic or dental product-development experience is an added advantage.