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[Apply Now] Principal Mechanical Engineer – Medical Devices

[Apply Now] Principal Mechanical Engineer – Medical Devices

Quest GlobalIndia
5 hours ago
Job description

1. Senior Technical Architect – Medical Devices P-112120

2. Mechanical Technical Lead – Medical Devices P-112584

Senior Technical Architect – Medical Devices P-112120

Key Responsibilities

  • Mechanical Design Engineer with 15-20 Years of experience
  • Minimum 8 years’ experience in medical devices, Renal dialysis machines and consumables design.
  • Hands on experience in all phases of medical device life cycle (NPD, sustenance, post market support)
  • Develop Medical device architecture (Mechanical)
  • Proficiency in Plastic, Sheetmetal and machined part design
  • Design for compliance with regulatory standards
  • Regulatory standards knowledge like IEC 60601-1, MDR 2017 / 745 or MDR 2017 / 746, QSR per 21 CFR Part 820, particular standards, collateral standards, FDA510K, UL, CE
  • Provide key inputs to the team, take proactive initiatives and thorough knowledge on RCA / troubleshooting.
  • Knowledge on Quality Management System as per ISO 13485
  • 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.
  • Experience in Obsolescence management.
  • Manage complete system Bill of materials.
  • Should be cost conscious towards the device and should take up Value Engineering initiatives.
  • Design documentation, review critical designs and release for Prototype / Production
  • 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 (External and Internal)
  • Proficiency in 3D tools like Solid works, Creo, etc.
  • Concept Design and Complete Engineering design
  • Good mechanical design skills with GD&T and tolerance stack up, FEA and CFD knowledge
  • Good knowledge on manufacturing processes- DFM, DFA, DFT
  • Material selection proficiency. Assess impact of alternate material and finalization with Supplier.
  • Labelling and Packaging design experience

Work Experience

  • Work experience with Mechanical part development / tool design, CAD drawings & Manufacturing Drawing
  • Good Customer from ending, Delivery Leadership experience as Tech Architect, good Team player, Team management skills.
  • 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.

    • 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.
  • Having Japanese Visa and willing to work on short term / long time onsite assignment will be added advantage.

    • Mechanical Technical Lead – Medical Devices P-112584

  • 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.
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    Principal Mechanical Engineer • India