Baxter Medical Devices
Location
Bangalore | India
Job description
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives-where your purpose accelerates our mission.
Your Role at Baxter:
Baxter's Respiratory Health business unit products expand therapies to better help patients and
physicians to manage chronic or acute respiratory and cardiac diseases (COPD, CHF, etc.). The earlier the treatment for these patients - the better the quality of life. The $150M business portfolio includes products for airway clearance and ventilation.
The role of Senior System Engineer is to contribute in design and development of a product or solution, from conception to design and verification/validation. You will a ppl y expert technical knowledge and engineering principles in the development of products and solutions. You will also p rovide guidance to other engineers for technical issues, design reviews, and complex problem resolution.
This position is based out of Bangalore and reporting to the Systems Manager f or Respiratory Health division of Front Line Care.
Essential Duties and Responsibilities :
Identify and define internal and external customer needs, functions, performance, usability and safety requirement 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 technical leadership to the development team 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 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.
Makes difficult design trade-offs and decisions about features, schedule, quality and cost.
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.
Excels in the application of principles of Reliability and Robustness in the development of products or solution .
Completes detailed, high quality technical documentation to capture and communicate designs.
As Lead integrator for the product proactively look out for integration issues during development tests and ensure module / system development is successful.
Actively engage with verification and validation engineers to aid in the development of verification scripts with good test coverage.
Your Team:
You will be r eporting to Systems Manager for Respiratory Health . This position does not have any direct reports. You will need to work collaboratively with R&D and cross functions.
Your Location:
The role is located in the BRD facility in Bangalore India.
What You'll Bring:
Bachelor's Degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field
5 to 10 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. Able to deliver on multiple projects simultaneously
Self-motivated with good interpersonal skills
Reasonable Accommodations
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