Senior Systems Verification Engineer
$96k - $132kBaxter Healthcare
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.
Your Role at Baxter This is where your work saves lives As a part of Infusion Therapies & Platforms (ITP) division, the Senior Systems Verification Engineer, contributes to System Verification Engineering vision that aligns with the organization's vision and strategic plan. Use proven understanding of engineering theory and best-practice in a variety of fields to lead sophisticated projects or programs within boundaries of quality, time and budget. Exhibit creativity and innovation in completing divisional and cross-functional/business unit goals and objectives. Contribute to the plans and leads project assignments in the evaluation, selection and adaptation of various techniques, procedures, and criteria with minimal mentorship. Ensures that quality is built into the design during new product development What you'll be doing
Your Role at Baxter This is where your work saves lives As a part of Infusion Therapies & Platforms (ITP) division, the Senior Systems Verification Engineer, contributes to System Verification Engineering vision that aligns with the organization's vision and strategic plan. Use proven understanding of engineering theory and best-practice in a variety of fields to lead sophisticated projects or programs within boundaries of quality, time and budget. Exhibit creativity and innovation in completing divisional and cross-functional/business unit goals and objectives. Contribute to the plans and leads project assignments in the evaluation, selection and adaptation of various techniques, procedures, and criteria with minimal mentorship. Ensures that quality is built into the design during new product development What you'll be doing
- Contribute to the planning, development and execution of system verification deliverables (test plans, test protocols, test cases, test reports, studies). Engage in test planning during design and development phases.
- Contribute to the validation efforts for laboratory equipment supporting infusion system testing (e.g., Infuscale, altitude chambers, environmental chambers, and related test systems).
- 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.
- Ensure appropriate traceability between system, subsystem, and software verification.
- Manage the integration of deliverables from subsystem teams, multi-functional teams (risk management, compliance, etc.) and external partners.
- Resolve competing constraints between interrelated functions (Engineering, Risk Management, Compliance, Reliability, Clinical, Human Factors, Regulatory)
- Implement configuration and change management through the complete product life-cycle.
- Build process improvements to streamline testing between system verification, subsystem and software verification.
- Ensure all program achievements in support of all phases of the product development lifecycle are completed on time, with appropriate quality, and in compliance with relevant laboratory standards and regulations.
- Participate and/ or leads design reviews.
- Bachelor's Degree in Mechanical, Electrical, Computer Science, Biomedical Engineering or equivalent
- 3+ years of relevant industry experience.
- Medical device industry experience is preferred.
- Proven organization skills and ability to collaborate with both technical and non-technical personnel.
- Solid understanding of ISO and/or FDA and other regulatory standards.
- Knowledge of Design controls, Lifecycle testing processes, MTBF analysis.
Vacancy posted 2 days ago
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