Principal Eng , System Verification

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Position Overview

Provides technical leadership for Medication Delivery System Verification. As Principal Engineer, lead technical team members in the application of standard system engineering principles, methods, and techniques to resolve difficult problems focused on system verification. 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 out on the progress to senior management.

Contributes to System Verification Engineering vision that aligns with the organization's vision and strategic plan. Utilizes solid understanding of engineering theory and best-practice in a variety of disciplines to manage complex projects or programs within boundaries of quality, time and budget. Provides direction to technical team members that are accountable for system verification engineering activities. Exhibits creativity and innovation in completing divisional and cross-functional/business unit goals and objectives.

Essential Duties and Responsibilities

o Provide Technical direction for Systems Verification and Validation Engineering staff and programs.

o Lead the planning, development and execution of system verification and validation deliverables (test plans, test protocols, test cases, test reports, studies). Engage in test planning during design and development phases.

o Contribute to the development and documentation of system requirements, systems architecture and design.

o Ensure appropriate traceability between system, subsystem, verification/validation and cross functional deliverables.

o Manage the integration of deliverables from subsystem teams, cross functional teams (risk management, compliance, etc.) and external partners.

o Resolve competing constraints between interrelated functions (Engineering, Risk Management, Compliance, Reliability, Clinical, Human Factors, Regulatory)

o Implementing configuration and change management through the complete product life-cycle, including verification and validation deliverables.

o Actively communicates and advocates team's capabilities and accomplishments.

o Recommends changes to policies and establishes procedures that affect immediate department/function.

o Create opportunities to automate testing and optimize test processes

o Create best practices and process improvements to streamline testing between system verification, subsystem and software verification.

o Ensures all program milestones 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.

o 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.

o Maintains an effective and collaborative working relationship with internal and external development partners across all levels and diverse cultures.

o Guides the team in investigations for identifying the root cause and drives action to prevent such issues recurring.

o Collaborate with other engineering teams within the organization.

o Guide, mentor, and provide direction to junior verification and validation Engineers.

o Ensure compliance to the product development process and Quality System requirements.

o Ensures good documentation and Good Manufacturing practices are followed in the Verification and Validation Process.

Qualifications

o Bachelor's Degree in mechanical, Electrical, Computer Science, Biomedical Engineering or equivalent, with approximately 10+ years of relevant industry experience.

o Healthcare industry experience preferred.

o Requires strong organization and communication skills, with the ability to interface with both technical and non-technical personnel.

o Strong knowledge of ISO, FDA and other regulatory standards is essential.

o Hands on experience in data analysis of Performance testing and Sample size calculations for variable/Attribute data

o Experience in Tools like Minitab(Data Analysis) /JIRA ( Defect )/ALM ( test Environment) etc.

o Demonstrated experience working with vendors with different models of engagement.

o Knowledge of Design controls, lifecycle testing processes, MTBF analysis.

o Must have demonstrated effective supervisory and people development skills.

o Ability to lead teams across multiple sites

o Ability to convince management on courses of action with minimal assistance using both written and verbal methods.

Preferred Candidates

. System Verification Engineers with Experience in Infusion pumps design verification testing.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

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