Principal Engineer, System Verification

• Provide Technical direction for Systems Verification and Validation Engineering staff and programs
• Lead the planning, development and execution of system verification and validation deliverables (test plans, test protocols, test cases, test reports, studies)
• Contribute to the development and documentation of system requirements, systems architecture and design
• Ensure appropriate traceability between system, subsystem, verification/validation and cross functional deliverables
• Manage the integration of deliverables from subsystem teams, cross functional teams (risk management, compliance, etc.) and external partners
• Resolve competing constraints between interrelated functions (Engineering, Risk Management, Compliance, Reliability, Clinical, Human Factors, Regulatory)
• 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
• Recommends changes to policies and establishes procedures that affect immediate department/function
• Create opportunities to automate testing and optimize test processes
• Create best practices and process improvements to streamline testing between system verification, subsystem and software verification
• 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
• 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
• Maintains an effective and collaborative working relationship with internal and external development partners across all levels and diverse cultures
• Guides the team in investigations for identifying the root cause and drives action to prevent such issues recurring
• Collaborate with other engineering teams within the organization
• Guide, mentor, and provide direction to junior verification and validation Engineers
• Ensure compliance to the product development process and Quality System requirements
• Ensures good documentation and Good Manufacturing practices are followed in the Verification and Validation Process

• Bachelor’s Degree in mechanical, Electrical, Computer Science, Biomedical Engineering or equivalent, with approximately 10+ years of relevant industry experience
• Healthcare industry experience 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
• Hands on experience in data analysis of Performance testing and Sample size calculations for variable/Attribute data
• Experience in Tools like Minitab(Data Analysis) /JIRA ( Defect )/ALM ( test Environment) etc.
• Demonstrated experience working with vendors with different models of engagement
• Knowledge of Design controls, lifecycle testing processes, MTBF analysis
• Must have demonstrated effective supervisory and people development skills
• Ability to lead teams across multiple sites
• Ability to convince management on courses of action with minimal assistance using both written and verbal methods

System Verification Engineers with Experience in Infusion pumps design verification testing

• Support for Parents
• Continuing Education/ Professional Development
• Employee Heath & Well-Being Benefits
• Paid Time Off
• 2 Days a Year to Volunteer