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Job Summary
Baxter’s Front Line Care business unit products expand therapies to better help patients and physicians to monitor & 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 $1.1B business portfolio includes products for airway clearance, cardiology & patient monitors.
You will be responsible for the overall technical direction and deliverables for Front Line Care products. Based on your significant technical expertise and leadership skills, you will also drive the full product development cycle from feasibility through lifecycle management. Assures that quality is built into the design during new product development. Proactively monitors the program and develops strategies to mitigate technical risks. Report on the progress on a routine cadence to senior management.
The role of Principal Engineer includes responsibility for developing creative solutions to challenging issues associated with the design, development, and sustaining engineering for our new and existing Front line care product portfolio. Possess solid “hands-on” technical abilities, an excitement and energy for product development, and a passion for the work and the impact it has on meeting the needs of patients. In addition, you will also be responsible for application of human factors engineering principles to the design, development, and testing of medical products while working with cross-functional program teams. This position is based out of Bangalore and reporting to the Manager, Systems Front-Line Care.
What you’ll be doing
- As a Principal Engineer Systems, responsible for end-to-end development & sustenance of the product, from capturing the user/marketing needs to final product release. Interact with customers and marketing to develop and refine user requirements.
- System engineering plays a critical role in product development, making sure the product meets all the functional and performance requirements. He/ She is responsible for making sure the manufacturing and service requirements are translated into product design.
- Lead the development and documentation of the product systems architecture and systems level design, including the decomposition of the system architecture and requirements into subsystem and interface specifications.
- Hands on Experience and knowledge in requirements of IEC62366, 60601-1, IEC62304 and associated guidance’s from FDA, EU MDR.
- Resolve competing constraints between interrelated functions (engineering, manufacturing, regulatory, marketing, etc.) required to deliver the product to market.
- Plan and execute system integration activities to minimize issues in systems verification and validation.
- Document traceability from requirements to verification activities, and from requirements to design entities.
- Resolve system-related technical issues by applying problem solving tools such as cause-and-effect diagrams and Pareto charts
- Adheres to Baxter Quality Management system & supports the quality audits.
- Plan, coordinate, perform, analyze and document study activities with focus on identifying user needs, intended user profiles, use environment and usability aspects.
- Analyze and define goals and requirements related to usability for the products.
- Plan, coordinate, perform, visualize and document concept of handling design
- Plan, perform and document evaluations of handling related product risks.
- Plan, perform, analyze and document usability evaluation activities according to scientifically accepted tools
- Identify and implement improvements to the internal processes within the competence area to secure that state of art is maintained
- Support in audits and assessments made by authorities and third parties
- Time and budget estimations for Human Factors activities where one or several resources are assigned.
- 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.
- 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.
- 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
What you’ll bring
- Graduate or Post-Graduate in Electrical, Mechanical, Biomedical, or related Engineering.
- An advanced technical degree is desired. Experience should include at least 8-12 years of relevant technical experience, including some technical leadership.
- Must possess a strong knowledge of engineering disciplines like Risk Management and Usability / Human Factors Engineering and solid knowledge of related disciplines, Electro/Mechanical, Systems, Fluid Mechanics, Materials Science, blowers, pumps, and control systems
- Experience in Medical Device Development, FDA Regulations and MDR.
- Demonstrated excellent skills in Human Factors Engineering techniques.
- Demonstrated understanding and capabilities within user centered design.
- Comprehensive knowledge of applicable usability related to standards and regulations
- Ability to coach less experienced Human Factors Engineers. Expertise to Usability Engineering Process
- Ability to decompose complex problems into actionable tasks, Structured, systematic, result and quality-oriented working.
- 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
- A demonstrated track record in system development in Medical Devices or highly regulated products such as military hardware.
- Have a proven track record of management/leadership effectiveness in a fast-paced environment. Proven ability to create results within budget, timeline, and product/project deliverables.
- Understanding manufacturing and design of electromechanical medical devices and systems.
- Familiarity with ISO, FDA, and other regulatory standards
- Demonstrated experience working with vendors with different models of engagement.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Reasonable Accommodations
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