Essential Roles and Responsibilities:

- Identify and define internal and external customer needs, functions, performance, usability and safety requirements for product or solution with thorough knowledge and understanding constraints - Business and Regulatory, Design trade-offs and Risk assessment early in the development cycle working independently or under the guidance of senior staff.
- Provide your technical expertise to ensure that the project successfully meets cost, quality and schedule targets throughout the product life cycle.
- Excels in the development of Use Case for product or solution based on intimate knowledge of customers and their environments. Use tools such as DOORS, POLARION or equivalent and excels in the management of requirements and decomposition of system level requirements to modules.
- Carry out risk management process in accordance with the EN ISO 14971 throughout product life cycle to ensure compliance and product safety.
- Identify development issues and facilitates in the resolution using optimal technology solutions. Supports in the Usability Engineering activities to ensure the application of human factor in the development of products or solutions to demonstrate compliance to IEC 62366 and FDA guidance.
- Knowledge in the application of principles of Reliability and Robustness in the development of products or solutions.
- Completes detailed, high quality technical documentation to capture and communicate designs.



Support integration issues during development tests and ensure module / system development is successful.
- Actively collaborate with software and hardware engineers to aid in the design development.
- Actively engage with verification and validation engineers to aid in the development of verification test plans with good test coverage.

Qualifications:

- Bachelors Degree in Mechanical engineering, Electrical Engineering, Electronics Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field
- 3 to 6 yrs of experience, mainly in System engineering function of Electro-Mechanical System Design

Education and Experience

- Experience in Medical Device development, FDA Regulations and MDR.
- Exposure to Usability Engineering Process Experience in QFD, Pugh Matrix, CTQ, DFR, DFX
- Robust interpersonal skills with the ability to collaborate with others in a team environment
- Understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards.
- Demonstrated experience in accomplishing objectives. Able to deliver on multiple projects simultaneously
- Self-motivated with good interpersonal skills

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Eng II, Systems (Karnataka)
🏢 BAXTER
📍 Karnataka