Roles & Responsibilities
- Derive requirements and specifications for systems and components.
- Create DFMEA, statement of work and other engineering documentations.
- Design with solid works CAD platform, create 2D drawings.
- Work with engineers across different engineering streams as needed.
- Collaborate with prototype and production suppliers.
- Design for the appropriate manufacturing process based on quantity estimates.
- Validate components and systems to specifications.
- Prototype various hardware projects.
- Document creation in line with ISO 14971 and 13485 standards
- Create ECR, ECO. • Create impact assessment for product changes.
- BOM creation.
- BE, M Tech. graduates in Mechanical Engineering
- Design Engineers with 3-5 years of work experience
- Medical device experience preferred
- Knowledge of FDA regulations and Medical Devices Directive 93/42/EEC
- GDP & GMP Experiences (Good Documentation Practice & Good Manufacturing Practice)
- Able to deliver with little oversight
- Experience with medium to high volume production
- Knowledge of relevant manufacturing process and a variety of engineering materials
- Knowledge of standard manufacturing processes
- Knowledge of common material properties