This is a Remote opportunity with 25% to 50% Travel required
The Manager, Process and Reliability Engineering will lead and develop the Biomedical maintenance, process, and reliability improvement program to reduce unplanned instrument downtime and increase overall equipment effectiveness by partnering with external Service Contract Suppliers, Biomedical Engineers/Techs, Equipment Process Owners, and Continuous Improvement Managers.
This position is a key leadership position to build a foundation for a TPM Total Productive Maintenance Zero Defect Culture by deploying the region's Maintenance and Reliability Program and applying the Quest Management System (QMS) principles and tools to meet our customer's service levels, increase lab productivity & safety, and reduce maintenance and operating costs.
The Maintenance & Reliability Program is built on Foundational Elements of Measurement, Standardization and Communication with 5 Strategic Pillars: Autonomous Maintenance, Focused Improvement, Professional Maintenance, Early Equipment Management, and Training & Development.The Quest Management System (QMS) is built on 7 practices: Hoshin Breakthrough Management, Voice of the Customer, Process Management, Continuous Improvement, Project Management, and Change Management.Continuously improve, evolve, and communicate the deployment of the regional maintenance & reliability program. Including, but not limited to the following elements:
Foundational: Standardize Instrument Lost Time Key Performance Indicators (KPls) and improvement tools by utilizing the EAM Enterprise Asset Management system (i.e. CMMS Computerized Maintenance. Management System), One Point Lessons (OPL) Visual Management, Failure Mode and Effects Analysis (FMEA) and Root Cause Analysis/Corrective & Preventive Action (RCS/CAPA) tools.Autonomous Maintenance (AM) - Improve Operator Maintenance through Basic Equipment Care to halt forced deterioration and stabilize equipment.Focused Improvement (Fl) - Drive Team focused Uptime and Operational Equipment Effectiveness Improvement on poorly performing equipment with unknown losses.Professional Maintenance (PM) - Improve Planned Maintenance with external Supplier Service Contract Suppliers and internal Biomedical Engineers (BME) to optimize life of the equipment and maintenance costs as volume changes over time.Early Equipment Management (EEM) - create faster & successful new equipment/automation start-ups by improving reliability and flow with early design/layout modifications (including 3P Pre-Production Preparation) and early deployment of foundational measures and tools.Training and Education (TE) - facilitate employee Maintenance related training utilizing One Point Lessons (OPL) and standard work tools.Lead and optimize the regional implementation of the CMMS / EAM System across Instrument Platforms to record and track equipment downtime and automate KPI Measurement. Metrics and provide end user training.Lead weekly multi-lab Instrument Platform Focused Improvement Meetings with Service Contract Suppliers, Biomedical Engineers/Techs, and Equipment Process Owners to reduce unplanned equipment downtime and increase operational equipment effectiveness.Establish standard Downtime Trackers with RCA Root Cause Analysis, Corrective & Preventive (CA/PA) Actions and transfer capabilities and leadership to Process Owners. Accelerate focused improvement by leading and facilitating equipment FMEA and Autonomous Maintenance (AM) Kaizen Workshops to establish baseline improvement actions and return equipment to standard operating conditions.Coach employees and external partners on the use of various Maintenance and Reliability tools, concepts, and practices to build self-sufficiency, sustainability, and scalability.Provide direct and/or Indirect leadership of internal Biomedical Engineers and Technicians across various regions to ensure a standard approach supporting the Maintenance and Reliability Program.Required Work Experience:
Demonstrated understanding, experience, and leadership in Maintenance & Reliability (Minimum 3 years).Demonstrated understanding, experience, and leadership in continuous improvement and process management, (Minimum 3 years).Preferred Work Experience:
Demonstrated understanding, experience, and leadership in Maintenance & Reliability, CCMS Computer Maintenance Management Systems and TPM Total Productive Maintenance (6+ years).Demonstrated understanding, experience, and leadership in continuous improvement, process management, project management and change management, including leading large or complex projects with multiple workstreams (6+ years).Physical and Mental Requirements:
Must be able to react to auditory warnings and messages.Can require prolonged period of standings in addition to bending, stooping, reaching & squatting.Knowledge:
Strong knowledge of Equipment Maintenance and Repair processes, preferably Precision Test Equipment in a Biomedical Environment.General understanding of Equipment Electrical & Mechanical Failure Modes, Root Cause, Corrective and Preventive Actions.Use and optimization of CCMS Computer Maintenance Management Systems and KPI Performance Management Systems.Understanding of external supplier contracted FSE Field Service Engineering Management and interaction with internal Maintenance and Repair Management.Knowledge of TPM Total Productive Maintenance, Reliability & Maintainability tools and techniques including Focused Improvement and Autonomous Maintenance.Development and use of Standard Work and Visual Management methods, including OPL One Point Lessons.Facilitation of FMEA Failure Mode and Effects Analysis and Equipment/Process M&I Material & Information Flow.Utilization of Lean Manufacturing Waste Identification and Elimination methods, including 8 Wastes, 5S and Quick Changeover.Use of Six Sigma or equivalent Improvement methods, including statistical and financial analysis and Problem-Solving.Skills:
Ability to influence business leaders and develop strong relationships with internal process owners and external suppliers.Effective written and verbal communication skills across multiple formats: formal Presentations, meetings, conference calls, e-mail, and memos.Knowledge and use of Core Continuous Improvement & Problem-Solving tools and methods, including Lean Manufacturing and Six Sigma. Proven ability to realize cost-savings attributed to efficiency gains, process improvements, etc.Experience with organizational transformation & change management.Other key skills include:Strategic planning and execution Financial & business acumenVendor relationship-cultivation and management Interpersonal skillsInterpersonal skillsData and statistical analysis Facilitating discussions and workshopsAbility to handle multiple projects simultaneously Skilled in Microsoft Word and Microsoft ExcelComfortable with Microsoft PowerPoint and Microsoft Project
EDUCATION
Bachelor’s Degree(Required), preferably in Engineering
LICENSECERTIFICATIONS
Certified Maintenance & Reliability Professional (CMRP) preferred
Formal Project Management training (Preferred)
Formal training in project management or continuous improvement methodologies (e.g., Six Sigma, Total Quality Management, Lean, Theory of Constraints) (Required)
PMI Project Management Professional (PMP) (Preferred)
Project Management (PMI) Certification (Preferred)
Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets