Senior Mechanical Architect / Principal Mechanical Engineer - Medical Devices - Renal Care portfolio

Senior Technical Architect – Medical Devices P-112120

Mechanical Technical Lead – Medical Devices P-112584

Must Have experience - Renal Care portfolio (Dialysis Machines, Dialysis Consumables)

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.