Job Description
This is where your work makes a difference.
At Baxter, we believe every person—regardless of who they are or where they are from—deserves 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 job—you will find purpose and pride.
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.
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, LNE,etc.)
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
Bachelor's 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 MDR. 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.
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
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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