Sr Engineer, System Verification

Baxter • Round Lake, IL

69d • $88,000 - $121,000

About The Position

As a part of Infusion Therapies & Technologies division, the Senior Engineer, System Verification, 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.

Requirements

• Bachelor's Degree in Mechanical, Electrical, Computer Science, Biomedical Engineering or equivalent, MS preferred.
• 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.

Responsibilities

• 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 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.
• Recommend changes to policies and establishes procedures that affect immediate department/function.
• 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 lead design reviews.
• Guide the team in investigations for identifying the root cause and drives action to prevent such issues recurring.
• Guide, mentor, and provide directions to junior verification engineers.
• Ensure compliance to the product development process and Quality System requirements.
• Ensure good documentation and Good Manufacturing practices are followed in the verification process.

Benefits

• 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), with the ability to purchase company stock at a discount.
• 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.
• Family and medical leaves of absence.
• Paid parental leave.
• Commuting benefits.
• Employee Discount Program.
• Employee Assistance Program (EAP).
• Childcare benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees