Lab Systems Principal Engineer

6029-MEDICAL DEVICE BUSINESS SERVICES Legal Entity • Irving, TX

6h • Hybrid

About The Position

The Lab Systems Principal Engineer is responsible for the Deployment and Lifecycle Management (LCM) of LIMS within MedTech Sites. This role follows local and enterprise procedures to deploy Digital LIMS solutions that meet Quality and Compliance expectations. Ongoing LCM ensures Business Unit needs are met, including regulation-required maintenance of digital/data assets. The role also develops business requirements with Information Technology partners to ensure digital solutions meet site and business needs. As part of quality process digitalization, the Principal Engineer identifies and materializes optimization and efficiency improvements facilitated through digitalization. The role actively engages with multiple sites, Business Units, and the Enterprise IT group.

Requirements

• University/Bachelor’s degree required in Life Sciences or Engineering.
• 8+ years of experience including postgraduate.
• 4+ years of experience in Managing or Developing Laboratory Information Management Systems (LIMS) application(s).
• Software Validation Process
• Verbal and written communication skills
• Project management
• Problem solving
• Six sigma and process excellence tools/methodologies
• Presentation skills
• Training/education methodologies & talent development

Nice To Haves

• Coaching
• Compliance Management
• Controls Compliance
• Digital Assurance
• Human-Computer Relationships
• Performance Measurement
• Process Improvements
• Process Optimization
• Quality Control (QC)
• Quality Standards
• Quality Validation
• Regulatory Compliance
• Researching
• Stakeholder Engagement
• Standard Operating Procedure (SOP)
• Subject Matter Experts (SME)
• Collaboration
• Technical Credibility

Responsibilities

• Responsible for leading tactical and technical efforts to deploy LIMS per strategic Roadmap.
• Development of technical solutions needs to be zoomed into WW strategy and zoomed into specific site needs.
• Lead Change Management with sites in the process of digitalization or digitalization solution replacement.
• Develop and train local leaders as Lab System Admins that will become local SME’s of the platform and process.
• Develop and deliver stakeholder and site leadership communication updates in support of ongoing deployments or LCM activities.
• Engages with Enterprise IT to develop requirements and monitor delivery of technical solutions that meet business needs.
• Establish opportunities for standardization and harmonization to facilitate rapid global scaleup of digital solutions.
• Responsible for communicating business-related issues or opportunities to next management level.
• Responsible for oversight of processes and procedures that govern LIMS platforms.
• Responsible for Finance oversight of deployments and maintenance: Cost savings, capital, expenses.
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior