Mech. Engineer

2 days ago

Bengaluru, Karnataka, India Quest Global Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Job Requirements

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.

Key Responsibilities

Mechanical Design Engineer (BE / Diploma in Mechanical or Equivalent) with 5-10 Years of experience

  • Minimum 3 years' experience in the medical device industry
  • Hands-on experience in all phases of medical device life cycle (NPD, sustenance, post market support)
  • Proficiency in Plastic, Sheetmetal and machined part design
  • Part, sub-system and product level concept Design, Complete Engineering design
  • Good knowledge of manufacturing processes
  • Design for compliance with regulatory standards
  • Regulatory standards knowledge like IEC , MDR 2017/745 or MDR 2017/746, QSR per 21 CFR Part 820, particular standards, collateral standards, etc.
  • Provide key inputs to the team, take proactive initiatives and thorough knowledge on RCA/troubleshooting.
  • Risk management documentation as per ISO 14971
  • DFMEA, PFMEA and SFMEA document preparation and control
  • Document and change management process in medical device industry using PDM/PLM software.
  • Manage complete system Bill of materials and document support
  • Prototype development and supplier management and detailed DFM reviews.
  • Support for Pilot lot assembly & production support
  • Support for maintenance of Design History file, Device History Record and Device Master Record documents
  • Support for Verification and Validation tests
  • Proficiency in 3D tools like Solid works, Creo, etc.
  • Proficiency in GD&T and tolerance stack up
  • Good experience in packaging & label design as per ISTA/equivalent standards
  • Prototyping, testing & product validation for medical devices

We are known for our extraordinary people who make the impossible possible every day. Questians are driven by hunger, humility, and aspiration. We believe that our company culture is the key to our ability to make a true difference in every industry we reach. Our teams regularly invest time and dedicated effort into internal culture work, ensuring that all voices are heard.

We wholeheartedly believe in the diversity of thought that comes with fostering a culture rooted in respect, where everyone belongs, is valued, and feels inspired to share their ideas. We know embracing our unique differences makes us better, and that solving the worlds hardest engineering problems requires diverse ideas, perspectives, and backgrounds. We shine the brightest when we tap into the many dimensions that thrive across over 21,000 difference-makers in our workplace.

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

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