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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.
Job Responsibility:
Design and develop medical device systems and digital platforms, ensuring compliance with regulatory and business standards from concept to commercialization
Create and maintain product and software architecture, user interface design, and specifications that meet customer needs and regulatory requirements
Utilize systems engineering and design thinking to define functional and performance requirements for products and systems
Model behaviors across systems and conduct risk analysis from a systems perspective
Perform risk management activities, including analysis, evaluation, and mitigation, in accordance with ISO 14971
Develop and maintain verification and validation plans, test protocols, and reports to comply with FDA and industry standards
Conduct integration and system validation testing for Kubernetes-based digital platforms in On-Prem and Cloud environments
Prepare technical documentation (design plans, traceability matrices, test reports) in compliance with FDA-approved quality processes for Class I/II and MDDS products
Train and mentor the systems team
Requirements:
Bachelor’s degree in Electronics Engineering and Communications or related field plus 8 years of related experience
Translate Customer/end user needs, design constraints, and regulatory mandates into comprehensive system requirements, including functional, non functional, and performance specifications for medical devices and health software
Perform comprehensive risk evaluation in compliance with ISO 14971, ensuring identification, analysis, and control of medical device risks
Analyze system behavior for complex medical products under FDA guidelines in accordance with IEC 60601-1 and IEC 80601-1 standards
Lead the verification and validation of medical devices and health software in strict accordance with IEC 62304 and IEC 82304, ensuring traceability, regulatory compliance, and adherence to FDA recognized software development lifecycle standards
Develop and maintain comprehensive verification and validation plans for medical devices and health software, including detailed test protocols, execution records, and test reports, ensuring full traceability, regulatory compliance with FDA requirements, and alignment with engineering best practices and standards such as 21CFR-820
Perform integration and validation testing of Kubernetes based medical device monitoring platforms across On Prem and Cloud, leveraging Docker, Kubernetes, MQTT, and RabbitMQ with secure API driven communication to ensure interoperability and compliance in regulated healthcare environments
Create and maintain regulatory compliant technical artifacts—including development plans, test protocols, traceability matrices, and verification/validation reports—in alignment with FDA requirements and medical device industry standards such as IEC 62304 and ISO 13485
Plan and prepare the test environment for integration of medical devices with Electronic Medical Record (EMR) systems, ensuring interoperability, data integrity, and patient safety in compliance with FDA regulations, IEC 62304 software lifecycle requirements, and HL7/FHIR interoperability standards
Expertise in IHE Patient Care Device (PCD) Alarm Communication Management Profile, which uses HL7 messaging standards to communicate between medical devices and alert management systems
Hands-on experience with PostgreSQL/MySQL clinical data repositories, ensuring precise data handling, integrity, and adherence to FDA and HIPAA regulations
20% international and domestic travel required to meet customers to understand user needs and clinical workflows
What we offer:
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP) with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service