Mechanical Engineer-
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Job Location:
Monthly Salary:
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
Key Responsibilities:
Design & Development
Lead end-to-end mechanical design of electro mechanical medical device components
and sub-assemblies from concept through production release.
Develop detailed 3D CAD models and 2D drawings using SolidWorks including
complex surface modelling for ergonomic and aesthetic design features.
Apply Geometric Dimensioning & Tolerancing (GD&T) principles to ensure design
intent fit and manufacturability.
Perform tolerance analysis and mechanical calculations to validate design robustness.
Select materials and manufacturing processes (injection moulding machining casting
sheet metal etc.) suitable for medical applications.
Support engineering builds and hands-on mechanical testing to evaluate design
functionality performance and reliability.
Participate in design brainstorming feasibility studies and FMEA sessions to identify
and mitigate risks early in the design cycle.
Collaborate closely with suppliers toolmakers and contract manufacturers to ensure
design feasibility cost-effectiveness and manufacturability.
Review supplier drawings tooling concepts and first article inspection (FAI) reports.
Drive Design for Manufacturability (DFM) and Design for Assembly (DFA)
improvements throughout the development process.
Generate and maintain engineering documentation including BOMs drawings ECOs
and test reports in compliance with ISO 13485 and FDA 21 CFR Part 820 design
control requirements.
Cross-functional Collaboration
Work closely with electrical software and systems engineers to ensure seamless
mechanical integration.
Coordinate with quality regulatory and manufacturing engineering teams
throughout the product lifecycle.
Mentor junior engineers and contribute to best practices in design methodologies
and documentation.
Qualifications & Skills:
Education:
Bachelors or Masters degree in Mechanical Engineering or related field from
reputed institutes (IIT NIT.. etc.)
Experience:
Experience in mechanical design for medical devices
Successfully worked as design engineer and was involved in the design of at least
one medical device during entire cycle of concept to production
Expert-level proficiency in SolidWorks is a must including surface and solid
modelling of complex geometries.
Strong understanding and practical application of GD&T (ASME Y14.5) and tolerance
stack-up analysis.
Expert-level proficiency in Design for Manufacturability (DFM) and Design for
Assembly (DFA) is a must
Experience in plastic injection moulding die casting machined components and
sheet metal design.
Hands-on experience in prototype testing fixture development and test data
analysis.
Knowledge of medical device design control risk management and regulatory
standards (ISO 13485 FDA QSR).
Design & Development
Lead end-to-end mechanical design of electro mechanical medical device components
and sub-assemblies from concept through production release.
Develop detailed 3D CAD models and 2D drawings using SolidWorks including
complex surface modelling for ergonomic and aesthetic design features.
Apply Geometric Dimensioning & Tolerancing (GD&T) principles to ensure design
intent fit and manufacturability.
Perform tolerance analysis and mechanical calculations to validate design robustness.
Select materials and manufacturing processes (injection moulding machining casting
sheet metal etc.) suitable for medical applications.
Support engineering builds and hands-on mechanical testing to evaluate design
functionality performance and reliability.
Participate in design brainstorming feasibility studies and FMEA sessions to identify
and mitigate risks early in the design cycle.
Collaborate closely with suppliers toolmakers and contract manufacturers to ensure
design feasibility cost-effectiveness and manufacturability.
Review supplier drawings tooling concepts and first article inspection (FAI) reports.
Drive Design for Manufacturability (DFM) and Design for Assembly (DFA)
improvements throughout the development process.
Generate and maintain engineering documentation including BOMs drawings ECOs
and test reports in compliance with ISO 13485 and FDA 21 CFR Part 820 design
control requirements.
Cross-functional Collaboration
Work closely with electrical software and systems engineers to ensure seamless
mechanical integration.
Coordinate with quality regulatory and manufacturing engineering teams
throughout the product lifecycle.
Mentor junior engineers and contribute to best practices in design methodologies
and documentation.
Qualifications & Skills:
Education:
Bachelors or Masters degree in Mechanical Engineering or related field from
reputed institutes (IIT NIT.. etc.)
Experience:
Experience in mechanical design for medical devices
Successfully worked as design engineer and was involved in the design of at least
one medical device during entire cycle of concept to production
Expert-level proficiency in SolidWorks is a must including surface and solid
modelling of complex geometries.
Strong understanding and practical application of GD&T (ASME Y14.5) and tolerance
stack-up analysis.
Expert-level proficiency in Design for Manufacturability (DFM) and Design for
Assembly (DFA) is a must
Experience in plastic injection moulding die casting machined components and
sheet metal design.
Hands-on experience in prototype testing fixture development and test data
analysis.
Knowledge of medical device design control risk management and regulatory
standards (ISO 13485 FDA QSR).
Key Skills
- Mechanical Design
- System Design
- FEA
- ASME Codes & Standards
- CAD
- Mechanical Knowledge
- Creo
- SolidWorks
- Mechanical Engineering
- Autocad
- HVAC Design
- Autodesk Inventor
