Eng II, Design Transfer

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Overview

This is where new knowledge is discovered. Baxter’s Research and Development teams work cross functionally to innovate, develop and introduce creative solutions for patients needs globally. From Scientists to Engineers, your work creates the products that save and sustain lives.

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Success Profile

What makes a successful Research and Development team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

Courage
Action Oriented
Collaborates
Cultivates Innovation
Manages Ambiguity
Drives Results

Eng II, Design Transfer

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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.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Reagan, Senior Research Scientist in the United States

“For me, the best thing about working at Baxter is being able to do work that’s important to people—especially patients—outside of Baxter's walls. Inside our walls, I get to work with a fantastic team, and we know we're making a difference.”

Meet Karthik, Director of Renal Care R&D - Digital Health & Co-President of the Asian Leadership Network Business Resource Group, United States

“I’m excited about my role because I believe that digital initiatives can make a tremendous impact on lives by allowing people to access the same therapies and have similar care — whether in a hospital, a healthcare clinic, or the patient’s home — anywhere in the world.”

Meet Amitha, Research Associate in India

“Coming from a non-healthcare academic background, my current role has offered ample opportunities to learn a lot of new things. Leaders at Baxter are motivating, help us grow and provide a collaborative environment. The role gives me opportunities to have technical discussions with peers and subject matter experts globally, to learn interacting with customers, and manage project deadlines and deliverables. I am excited about shaping my career here at Baxter.”

Join Our Talent Community

We're grateful for your interest in a career with Baxter, and would like to get to know you. Joining our Talent Community is a great way to stay connected, learn more about Baxter, and help our recruiters find you if there's an opportunity that aligns with your background, skills and interests.

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Eng II, Design Transfer

Overview

Success Profile

Eng II, Design Transfer

Address

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Hear from Our Employees

Meet Reagan, Senior Research Scientist in the United States

Meet Karthik, Director of Renal Care R&D - Digital Health & Co-President of the Asian Leadership Network Business Resource Group, United States

Meet Amitha, Research Associate in India

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Join Our Talent Community