Baxter
Healthcare
EngII,SystemsC&S
Neural analysis suggests this role is
optimal for Junior candidates.
“Eng II, Systems C&S at Baxter. Skills: Codes and Standards, System Engineering, Risk Management, Product Development, Compliance Testing. The Engineer II contributes to the design and development of medical devices from conception through verification and validation, applying expert technical knowledge to ensure compliance with applicable codes and standards. This role involves identifying customer needs, executing compliance testing, managing risk, and leading integration efforts to ensure prod”
What You'll Achieve.
Demonstrated experience in accomplishing objectives and the ability to deliver on multiple projects simultaneously.
Industry & Context.
Reliability; Robustness
What They're Looking For.
Must Have
Bachelor's Degree in Mechanical engineering, Electrical Engineering, Electronics Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field. 3 to 8 years of experience in Codes and Standards, testing & System engineering function of Electro-Mechanical System Design. Demonstrated experience in accomplishing objectives and ability to deliver on multiple projects simultaneously.
Nice to Have
Exposure to Usability Engineering Process. 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.
What You'll Do.
The Engineer II contributes to the design and development of medical devices from conception through verification and validation
applying expert technical knowledge to ensure compliance with applicable codes and standards. This role involves identifying customer needs
executing compliance testing
and leading integration efforts to ensure product safety and regulatory approval from bodies like DQS
How You'll Work.
Team & Collaboration
The role requires collaboration with verification and validation engineers, QA/RA teams, and R&D teams to ensure product registration, compliance, and successful audits. Interpersonal skills are essential for effective teamwork.
Communication Scope
Technical documentation
Process & Methodology
QFD, Pugh Matrix, CTQ, DFR, DFX
Full 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 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 establishing compliance to codes and standards applicable to the product. You will also provide guidance to other engineers for technical issues, design reviews, and complex problem resolution. Essential Duties & 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, C&S assessment early in the development cycle working independently or under the guidance of senior staff Execute compliance testing as
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