Director Mechanical Engineering - Medical Devices | Renal Care | Dialysis

Description

• Lead team effectively and work closely with customers. Project scheduling and planning.
• Support for maintenance of Design History file, Device History Record and Device Master Record documents
• Support for Verification and Validation tests
• Prototype development and supplier management and detailed DFM reviews.
• Design Control documentation for Renal care disposables products
• Design for compliance with regulatory standards
• Manage complete system Bill of materials.
• Support for Verification and Validation tests (External and Internal)
• Develop Medical device architecture (Mechanical)
• DFMEA, PFMEA and SFMEA document preparation and control
• Support for Pilot lot assembly & production support
• Provide key inputs to the team, take proactive initiatives and thorough knowledge on RCA/troubleshooting.
• Document and change management process in medical device industry using PDM/PLM software.
• Design documentation, review critical designs and release for Prototype/Production

Requirements

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

Experience : 18 - 25 Years

Work Experience

• Good knowledge on ISO 13485 QMS, IEC Standards (General Safety, Particular & Collateral) and MDR.
• Proficient use of enabling technology, computer and time management skills.
• Material selection proficiency. Assess impact of alternate material and finalization with Supplier.
• Minimum 6 years’ experience in medical devices industry, Renal dialysis machines and consumables design.
• Proficiency in Carrying out Tests – Functional test, Critical IEC tests & Particular standards testing.
• Experience in conducting design reviews, design verification, and validation activities to ensure compliance with regulatory requirements and industry standards
• Proficient use of enabling technology, computer, and time management skills.
• Ability to adapt to changing priorities and work in a fast-paced, dynamic environment while maintaining attention to detail and quality standards
• Mechanical Design Engineer with 8-12 Years of experience
• Good knowledge on ISO 13485 QMS, IEC Standards (General Safety, Particular & Collateral) and MDR
• Work experience with Mechanical part development/tool design, CAD drawings & Manufacturing Drawing
• Mechanical Design Engineer with 15-20 Years of experience
• Experience in Obsolescence management.
• Good Customer from ending, Delivery Leadership experience as Tech Architect, good Team player, Team management skills.
• Ability to support engineers by providing new or alternative design solutions and contribute to product development decisions.
• Work experience with Mechanical part development, CAD drawings & Manufacturing Drawing.
• Strong communication skills to effectively collaborate with cross-functional teams and external stakeholders in the medical devices industry.
• Good mechanical design skills with GD&T and tolerance stack up, FEA and CFD knowledge
• Having Japanese Visa and willing to work on short term/long time onsite assignment will be added advantage.
• Hands on experience in all phases of medical device life cycle (NPD, sustenance, post market support)
• Good knowledge on manufacturing processes- DFM, DFA, DFT
• Labelling and Packaging design experience
• Knowledge on Quality Management System as per ISO 13485
• Minimum 8 years’ experience in medical devices, Renal dialysis machines and consumables design.
• Knowledge in Product Life Cycle management and Supplier transfer activities for Mechanical components
• Proficiency in GD&T and tolerance stack up
• Experience in Sustenance activities in medical products/ Healthcare business
• Experience in medical devices industry is mandatory, Renal dialysis machines and consumables design
• Risk management documentation as per ISO 14971
• Continuous improvement mindset, identifying opportunities to enhance design processes, reduce costs, and improve product performance
• Ability to take initiatives and drive the project to completion.
• Proficiency in 3D tools like Solid works, Creo, etc.
• Knowledge of Product Life Cycle management and Supplier transfer activities for Mechanical components.
• Expertise in Change Management process.
• 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
• Expertise in Change Management process. Experience in Sustenance activities in medical products/ Healthcare business.
• Experience in leading a team of mechanical engineers in the medical device industry, providing guidance, mentorship, and technical expertise
• Ability to collaborate with cross-functional teams including R&D, Quality, Regulatory, and Manufacturing to ensure successful product development and launch
• Excellent communication skills to effectively communicate with internal and external stakeholders, presenting technical information clearly and concisely
• Knowledge of international regulations and standards related to medical devices, ensuring products meet global market requirements
• Proficiency in Plastic, Sheetmetal and machined part design

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance