Mechanical Architect

4 days ago

Chennai Tamil Nadu, India Quest Global Full time

**Job Requirements**:

- Mechanical Design Engineer (BE / Diploma in Mechanical or Equivalent) with 14+ Years of experience
- Minimum 8 years’ experience in the medical device industry
- Hands-on experience in all phases of medical device life cycle (NPD, sustenance, post market support)
- Develop Mechanical architecture for medical devices
- 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 60601-1, 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.
- Experience in Obsolescence management.
- Manage complete system Bill of materials and document support
- 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
- Experience in leading a team in NPD/ Sustenance projects
- 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
- Material selection proficiency. Assess the impact of alternate material and finalization with Supplier.
- Cost conscious while material & process selection

**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**:

- 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.

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