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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.
Job Responsibility:
Lead planning, development and execution of system verification deliverables (test plans, test protocols, test cases, test reports, studies) and provide technical direction to the team.
Lead validation efforts for laboratory equipment supporting infusion system testing.
Develop and execute validation protocols, test plans, and reports in alignment with FDA, ISO, and equipment validation best practices.
Perform IQ/OQ/PQ activities for lab equipment and ensure complete traceability from requirements through test execution.
Contribute to the development and documentation of system requirements, systems architecture and design.
Create best practices, process improvements and traceability to streamline testing between system, subsystem, and software verification.
Implementing configuration and change management through the complete product life cycle, including verification and validation deliverables.
Actively communicates and advocates team's capabilities and accomplishments.
Create opportunities to automate testing and optimize test processes.
Participate and/or lead design reviews.
Guide team in state of art V&V practices, QMS processes and on applicable regulations/Standards, country specific requirements.
Guide team in investigations for identifying root cause and drives action to prevent recurrence.
Guide, mentor, and provide direction to junior verification and validation engineers.
Requirements:
Bachelor's degree in Mechanical, Electrical, Computer Science, Biomedical Engineering or related field.
5+ years of relevant industry experience.
Medical device industry experience is preferred.
Strong organization and communication skills, with the ability to interface with both technical and non-technical personnel.
Strong knowledge of ISO, FDA and other regulatory standards is essential.
Knowledge of Design controls, lifecycle testing processes, MTBF analysis.
Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
Ability to lead teams across multiple sites.
Demonstrated experience with test automation preferred.
Nice to have:
Medical device industry experience
Demonstrated experience with test automation
What we offer:
Support for Parents
Continuing Education/Professional Development
Employee Health & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage starting day one
Basic life, accident, short-term and long-term disability insurance
Business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP) with company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service