Your Role at Baxter
This is where your work saves lives
As a part of Infusion Therapies & Platforms (ITP) division, the Principal Systems Verification Engineer, provides technical leadership to the System Verification team. Plans and leads project assignments in the evaluation, selection and adaptation of various techniques, procedures, and criteria with minimal guidance. Based on significant process and technical expertise, reviews and approves verification plans and methods and provides general direction to verification engineering staff. Ensures that quality is built into the design during new product development. Reports on the progress to senior management. Contributes to System Verification Engineering vision that aligns with the organization's vision and strategic plan. Exhibits creativity and innovation in completing divisional and cross-functional/business unit goals and objectives.
What you'll be doing
- 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 (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.
- 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. Leverage and enhance existing automation framework for system testing.
- Participates and/ or leads design reviews. Guides the team in the state of art V&V practices, QMS processes and on the applicable regulations / Standards, country specific requirements.
- Guides the team in investigations for identifying the root cause and drives action to prevent such issues recurring.
- Guide, mentor, and provide direction to junior verification and validation engineers.
What you will bring
- 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.
- Requires 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.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $112,000 to $154,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
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US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site:
