Eng II, Design Transfer

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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 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.

The role of Engineer II Design Transfer is to contribute to a seamless design transfer of a product or solution from conception of design transfer requirements manufacturing transfer of DMR and validation. You will apply expert technical knowledge and engineering principles in the development of test & manufacturing specification establishing compliance as applicable to the product. You will also provide guidance to other engineers for technical issues design reviews and complex problem resolution

Essential Duties and Responsibilities

Establish standard methods for manufacturing testing & requirements thereof

Compile the inputs and document the requirement to Production Safety Test System Requirements (TSR)

Responsible to maintain the Production Safety Test System Requirements.

Own creation Review and Disposition Documents such as manufacturing test specifications.

Use tools such as DOORS POLARION or equivalent and excels in the management of requirements and decomposition of system level requirements to modules and their respective compliance requirements

Use tools like AGILE for PDLM management

Carry out risk management process in accordance with the EN ISO 14971 throughout product life cycle to ensure compliance and product safety

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 manufacturing requirements

Lead the effort in complying with IEC 60601-1 and collateral standards for manufacturing tests to stay compliant to notified bodies requirements (DQS UL ETL TUV LNEetc.)
Provides support during Notified Body audits & follow-ups

Collaborate with contract manufacturers in context of manufacturing requirements and govern to sustain the validated status of manufacturing and testing

Collaborate with manufacturing and process engineering from Baxter Manufacturing sites to sustain the compliant and validated status of manufacturing and testing of the products.

Qualification Education and Experience

Bachelors Degree in Mechanical engineering Electrical Engineering Electronics Engineering Software Engineering Computer Science Bio-Medical Industrial Engineering or related field

3 to 8 yrs of experience mainly in Manufacturing & testing function of Electro-Mechanical System Design.

Experience in Medical Device development FDA Regulations and 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.

Excellence in Medical Devices safety (IEC 60601-1 and collaterals for medical devices like cardiology patient monitoring and respiratory therapies) FDA Regulations or other applicable regulatory requirements.

Excellence in Medical Device software life cycle processes (IEC 62304) EMI/ EMC requirements REACH ROHS and Biocompatibility.

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

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