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
iso 13485
iec standards
solidworks
gd&t
6+ years
renal dialysis
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
Information not given or found
Training + Development
Information not given or found
Interview process
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Visa Sponsorship
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Security clearance
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Company
Overview
25 Years
Company Age
The company was founded over 25 years ago with the mission to tackle tough engineering problems.
18 Countries
Global Reach
The company operates across 18 countries, demonstrating its extensive global presence.
Top 10
Client Prestige
The company works with Fortune top-10 clients, showcasing its high-profile partnerships.
$60 Start
Humble Beginnings
The company was founded with just $60, growing into a global engineering powerhouse.
By blending deep technical know‑how with digital innovation, it evolved into a global engineering partner.
Projects range from next‑gen automotive safety systems and AI‑driven semiconductors to cutting‑edge aerospace and defense platforms.
Its financial growth is steady—built on recurring partnerships with Fortune‑top‑10 clients across key sectors.
A hallmark project: sustaining global EMS/ADMS energy‑management software for a major utilities provider.
Another standout: accelerating MRI development and support globally for a leading MedTech firm.
Its edge lies in full‑lifecycle delivery—concept, design, embedded software, manufacturing support, digital sustenance.
Known for foresight, the firm not only solves challenges but anticipates and prevents them.
Culture + Values
Aspiration
Humility
Hunger
Customer focus
Collaboration
Integrity
Environment + Sustainability
500K Trees
Planting Initiative
Commitment to plant 500,000 trees by 2025 to enhance environmental sustainability.
113K Tons CO₂
Carbon Absorption
Trees planted are projected to absorb 113,000 tons of CO₂ over the next two decades, significantly contributing to carbon reduction efforts.
Adopt renewable and clean energy sources, environmentally sound technologies and industrial processes
Striving for land‑degradation neutrality and improved resource consumption
Received State Energy Conservation Award 2023 (buildings category, Kerala)
Awarded National-level SEEM Gold award 2022 for Energy Efficiency
Supported climate action through decarbonization initiatives
Inclusion & Diversity
17,000+ students
STEM education impact
Supported over 17,000 underserved students through STEM education programs, fostering accessibility and opportunities in science, technology, engineering, and math fields.
Committed to advancing women in engineering via scholarships and vocational training (Smile Foundation, IEEE)
Global culture built on ensuring everyone feels seen, valued and heard
Employees accountable for embedding inclusion and respect in workplace culture
“Care for people” cultural pillar reflected via stories shared during Pride Month
Culture Advocate Network celebrates multiple cultures and identities year-round
Gender equality is a strategic ESG pillar focused on increasing female representation