- Under minimal supervision, research, design, develop, modify, and verify components/modules for medical devices.
- Translate design inputs to engineering specifications and produce sub-system level designs; Develop and analyze solutions, prototyping one or more options to provide proof of concept.
- Demonstrate understanding of customer needs and design inputs; Demonstrate proficiency with product s intended use and clinical procedures.
- Responsible risk-taking and risk management.
- Follow fundamental industry standards, design requirements and test strategies which apply to regulatory requirements.
- Independently create or refine engineering documentation, such as the Design History file.
- Working knowledge of (V&V) of medical device , Design verification testing, Design confidence testing, and product validation experience
- Follow R&D procedure like design controls and risk management, per the Quality Management System- ISO 13486, ISO 14971, EUMDR/ MDD requirements
Minimum Qualifications (Required):
- Preferable Bachelor s/ Master s in Mechanical Engineering can consider Biomedical engineering as well; 2- 6 years of relevant work experience in product development of mechanical engineering.
- Experience and hands on with design tools like Creo, Windchill, release of design through change management. Good to have hands on with UG NX.
- Skilled in interpreting design, analyzing and driving design changes, and collaborating across different functions for DFM, design for inspection, material selection.
- Basic working level of GD&T and tolerance analysis
- Good to have understand medical domain and clinical setting.
