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.