Lead Mechanical Engineer – Medical Devices

Job Title

At Quest Global, it's not just what we do but how and why we do it that makes us different. With over 25 years as an engineering services provider, we believe in the power of doing things differently to make the impossible possible. Our people are driven by the desire to make the world a better place—to make a positive difference that contributes to a brighter future. We bring together technologies and industries, alongside the contributions of diverse individuals who are empowered by an intentional workplace culture, to solve problems better and faster.

Job Requirements

Mechanical Design Engineer with 8-12 years of experience

Minimum 6 years' experience in medical devices industry, Renal dialysis machines and consumables design.

Hands on experience in all phases of medical device life cycle (NPD, sustenance, post market support)

Experience in leading a team of mechanical engineers in the medical device industry, providing guidance, mentorship, and technical expertise

Excellent communication skills to effectively communicate with internal and external stakeholders, presenting technical information clearly and concisely

Experience in conducting design reviews, design verification, and validation activities to ensure compliance with regulatory requirements and industry standards

Knowledge of international regulations and standards related to medical devices, ensuring products meet global market requirements

Continuous improvement mindset, identifying opportunities to enhance design processes, reduce costs, and improve product performance

Ability to adapt to changing priorities and work in a fast-paced, dynamic environment while maintaining attention to detail and quality standards

Passion for innovation and staying updated on emerging technologies and trends in the medical device industry

Ability to collaborate with cross-functional teams including R&D, Quality, Regulatory, and Manufacturing to ensure successful product development and launch

Develop Medical device architecture (Mechanical)

Design for compliance with regulatory standards

Design Control documentation for Renal care disposables products

Risk management documentation as per ISO 14971

DFMEA, PFMEA and SFMEA document preparation and control

Prototype development and supplier management and detailed DFM reviews.

Support for Verification and Validation tests

Proficiency in 3D tools like Solid works, Creo, etc.

Proficiency in GD&T and tolerance stack up

Work Experience

Work experience with Mechanical part development, CAD drawings & Manufacturing Drawing.

Proficiency in Carrying out Tests – Functional test, Critical IEC tests & Particular standards testing.

Expertise in Change Management process. Experience in Sustenance activities in medical products/ Healthcare business.

Good knowledge on ISO 13485 QMS, IEC Standards (General Safety, Particular & Collateral) and MDR.

Ability to take initiatives and drive the project to completion.

Lead team effectively and work closely with customers. Project scheduling and planning.

Desired Skills

Experience in medical devices industry is mandatory, Renal dialysis machines and consumables design

Knowledge of Product Life Cycle management and Supplier transfer activities for Mechanical components.

Ability to support engineers by providing new or alternative design solutions and contribute to product development decisions.

Proficient use of enabling technology, computer, and time management skills.

Strong communication skills to effectively collaborate with cross-functional teams and external stakeholders in the medical devices industry.