Eng II, Systems

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.

Here you will find more than just a jobyou will find purpose and pride.

Baxters 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

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 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

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

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

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information.

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