Principal Mechanical Engineer – Medical Devices

Senior Technical Architect – Medical Devices P-

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-

• 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.