This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
You will be responsible for the development of solutions to drive product development for new and existing components of the Medication delivery portfolio. The successful candidate will possess solid “hands-on” technical abilities, demonstrate excitement and energy for product development, and a passion for their work and the impact it has on meeting the needs of patients.
What you’ll be doing
- Strategizing and planning Verification activities independently/along with other leads
- Verification and validation of Software as a system using manual and automated test methods.
- Creation and execution of Verification and Validation plans, including coordinating efforts of test personnel inside and outside the Design Verification and Validation group.
- Reviewing test procedures, test input documents and test results
- Defining test setups and environment required for test execution
- Driving Challenging verification, sampling strategy & Non-functional req. tests
- Documenting any design defects (product non-conformances) discovered. Interfacing with other engineering disciplines to research, correct, and close design defects.
- Publishing test reports, defect summary report, performing defect analysis, driving defects to closure
- Managing traceability from requirements to verification
- Ensuring that the testing abides by the business Engineering Quality Procedures (QMS), Phased Review Discipline and regulatory needs of the applicable markets
- Development, implementation, and documentation of verification techniques.
- Participation in project meetings, project reviews, and specification reviews, Sprint Planning, Release Planning, Daily Scrums
- Development of new test systems and tools and maintenance of existing test systems
- Identifying and reporting any quality or compliance concerns and taking immediate corrective actions as required
- Interacting with global teams to promote consistency and maximize synergy
- Communicating effectively & impactfully in a cross-functional, multi-cultural, global environment
- Participating in and driving SW FMEA, dFMEA, FTA to define Risk Based Test Strategy
- Demonstrating Good structured approach for DSM, DBT
- Leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
What you’ll bring
- Bachelor’s or master’s degree in engineering/science or equivalent
- At least 10+ years of experience out of which at least 2 years of experience as a Verification Lead at system-level for products that include Hardware and Software.
- Good knowledge of testing methodologies and processes, including manual, automated, standards and compliance testing
- Demonstrated skills for planning and coordinating verification and validation activities for New Product Development programs at a sub-system level.
- Demonstrated abilities and skills in working, influencing and communicating in a diverse global environment
- Demonstrated problem-solving and leadership skills
- Strong influential and communication skills
- Knowledge of medical device software development is highly preferred including knowledge of standards such as IEC 62304, ISO 14971
Desired Characteristic
- Experience of having led verification for large and complex programs that includes stringent regulatory requirements and demonstrated automation implementation experience
- Advanced ISTQB Certification
- An engineer with Black BELT certification will be added advantage
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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