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Baxter's Front Line Care business products expand Diagnosis & Therapies to better help patients and physicians to manage chronic or acute respiratory and cardiac diseases (COPD, CHF, etc.). The earlier the diagnosis & treatment for these patients – the better the quality of life. The $1.2B business portfolio includes products for Cardiology, Patient monitoring, airway clearance, ventilation and Intelligent diagnostics. The role of Engineer II , Product Owner is to contribute in design and development of a product or solution, from conception to design and verification/validation. You will apply expert technical knowledge and engineering principles in the development of products and solutions. You will collaborate with cross functional team for technical issues, design changes, design reviews, and complex problem resolution
Job Responsibility
Identify and define internal and external customer needs, functions, performance, usability and safety requirement for product or solution
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
Requirements
Bachelor's 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
Experience in Medical Device development, FDA Regulations and MDR
Exposure to Usability Engineering Process
Experience in QFD, Pugh Matrix, CTQ, DFR, DFX
Strong 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