V&V Engineer – Medical Devices

3 weeks ago

india QuEST Global Services Pte. Ltd Full time

Quest Global is an organization at the forefront of innovation and one of the world’s fastest growing engineering services firms with deep domain knowledge and recognized expertise in the top OEMs across seven industries. We are a twenty-five-year-old company on a journey to becoming a centenary one, driven by aspiration, hunger and humility.

We are looking for humble geniuses, who believe that engineering has the potential to make the impossible, possible; innovators, who are not only inspired by technology and innovation, but also perpetually driven to design, develop, and test as a trusted partner for Fortune 500 customers.

As a team of remarkably diverse engineers, we recognize that what we are really engineering is a brighter future for us all. If you want to contribute to meaningful work and be part of an organization that truly believes when you win, we all win, and when you fail, we all learn, then we’re eager to hear from you.

The achievers and courageous challenge-crushers we seek, have the following characteristics and skills:
 

Roles & Responsibilities:

Mechanical Design Engineer/V&V Engineer with 8-10 Years of experience Minimum 5 years’ experience in medical device industry Strong hold on process knowledge of the Medical Device Lifecyle (all phases) Proficiency in Plastic & Sheetmetal part design Proficiency in 3D tools like Solid works, Creo, etc. Mechanical Concept Designs for NPD and Fixture design Experience in Test Protocol preparation and review (V&V) Risk Management documentation as per ISO 14971 Proficiency in FMEA (Design, System and Process) Material selection expertise. Assess impact of alternate material and finalization with Supplier. Experience in Proto Development and assembly Labelling and Packaging design experience Good knowledge in Mechanical CAD, PDM, PLM as per requirement Assembly integration and testing Must be an effective communicator at all levels (phone, e-mail & verbal) Adhere to company’s policies, codes and practices.

Required Skills (Technical Competency):

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 customer.

Desired Skills:

Knowledge in 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.

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