Capgemini Engineering is seeking a highly skilled Mechanical Engineer to join our dynamic team. This role emphasizes CAD design using Creo software. In this role, you will collaborate with cross-functional teams, ensuring the delivery of innovative, compliant, and CAD models & engineering drawings, that meets standards for medical device industry.

Primary Responsibilities:
Mechanical Product Development: Lead the end-to-end mechanical product development process for medical devices, including the conceptualization, CAD design, and validation of models in close collaboration with production and quality teams.

Cross-Functional Collaboration: Collaborate closely with prototype testing, production, and quality teams, building strong rapport to effectively deliver high-intensity, fast-paced project outcomes when required.

Quality Management & Change Management Systems: Manage quality documentation and approval workflows in compliance with ISO 13485 and FDA QSR. Demonstrated expertise in engineering change requests (ECRs), change orders (COs), and formal workflow approval processes in QMS tools.

Design Specifications & Controls: Define performance criteria, select appropriate materials, and ensure adherence to medical device design controls in compliance with regulatory standards.

Process Improvement & Feasibility: Identify areas for continuous improvement in technical CAD drawings, processes, and technologies, while conducting detailed feasibility studies, material evaluations, and performance testing.

Production Readiness & Regulatory Compliance: Supervise production activities to ensure alignment with design-for-manufacturability (DFM) principles, while ensuring all CAD solutions comply with relevant regulatory frameworks and industry standards.

Qualifications:
Educational Background: Master’s degree in Mechanical Engineering or a related field.

At least five years of professional experience, with two to three years in medical device development preferred.

Proficiency in mechanical design for devices and plastic components, with expertise in part design, sheet metal design principles and GD&T.

Demonstrated ability to work independently and collaborate effectively with teams remotely, managing tasks across geographically diverse locations.

Technical Skills:
Advanced proficiency in 3D modelling using CREO (mandatory)

In-depth knowledge of robust design processes and GD&T

Fluent in English, with the ability to collaborate effectively across diverse cultural settings and international teams

Work Type:
Position may be hybrid, offering flexibility between on-site and remote work based on assignment needs

Willingness and flexibility to travel as required

Capgemini Engineering offers you a work environment that is characterized by innovation. As a consultant at Capgemini Engineering, you are part of something bigger. Together with our partners we are facing exciting challenges whilst creating the future! Join us and get the future you want!

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