Eng II, Systems

Reposted Yesterday
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Bangalore, Bengaluru Urban, Karnataka, IND
In-Office
Mid level
Healthtech • Other
The Role
Contribute to design and development of electro-mechanical medical devices from concept through verification/validation. Define and decompose requirements, perform risk management (ISO 14971), support usability engineering (IEC 62366), collaborate with software/hardware teams, and develop high-quality technical documentation and verification test plans to meet regulatory and business constraints.
Summary Generated by Built In

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 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 Roles 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:

Bachelor's 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.

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.

Skills Required

  • Bachelor's degree in Mechanical, Electrical, Electronics, Software Engineering, Computer Science, Biomedical, Industrial Engineering or related field
  • 3 to 6 years experience in systems engineering function of electro-mechanical system design
  • Experience in medical device development and knowledge of FDA regulations and MDR
  • Experience with requirements management tools (DOORS, POLARION or equivalent)
  • Familiarity with risk management per EN ISO 14971
  • Exposure to usability engineering process and IEC 62366 compliance
  • Experience with design tools/approaches: QFD, Pugh Matrix, CTQ, DFR, DFX
  • Understanding of FDA, ISO and IEC design control procedures, regulations and standards
  • Ability to create detailed technical documentation and verification test plans
  • Strong interpersonal skills and ability to collaborate in cross-functional teams
  • Ability to manage multiple projects and deliver objectives

Baxter International Inc. Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Baxter International Inc. and has not been reviewed or approved by Baxter International Inc..

  • Healthcare Strength Health coverage begins on day one and includes medical, dental, and company-paid life and disability, indicating robust protection. This breadth of coverage is positioned as a strong component of the total rewards package.
  • Retirement Support A 401(k) with company match and related retirement programs support long-term savings. An additional savings infrastructure enhances overall financial security for many roles.
  • Leave & Time Off Breadth PTO scales with tenure and is complemented by paid holidays and meaningful paid parental leave. The scope of time-off programs contributes to a well-rounded benefits offering.

Baxter International Inc. Insights

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The Company
HQ: Deerfield, IL
35,858 Employees
Year Founded: 1931

What We Do

Every day, millions of patients, caregivers and providers around the world rely on Baxter’s leading portfolio of diagnostic, critical care, nutrition, kidney care, hospital and surgical products and solutions. For 90 years, we’ve been making an impact at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make it happen. With products, therapies and digital health solutions available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. We welcome Hillrom to Baxter, where we are uniting to advance patient care worldwide. We’re building on the strengths of two historically innovative and socially responsible companies that will better serve our patients, customers and communities.

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