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The Sr. Reliability Engineer collaborates with a multidisciplinary team responsible for reliability optimization in GMP Product Development and Manufacturing facilities at the Collagen Manufacturing Center (CMC) using metrics, statistical techniques, sustainability initiatives, and Best Engineering Practices.  The incumbent develops and implements plans for Reliability Centered Maintenance (RCM), continuous improvement, manufacturing sustainability, conservation of critical utilities, and Asset Lifecycle Management.  This role works closely with the Product Development, Operations, Maintenance, and Project Engineering staffs to specify, modify, acquire or maintain equipment necessary to achieve uninterrupted supply chain. The incumbent ensures that reliability enhancements to facilities and manufacturing equipment protect the identity, quality, durability, reliability, safety, and effectiveness of medical devices and, thereby, protect patient safety.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Safety - Ensures that all team members receive training from Integra LifeSciences’ Safety department, and are knowledgeable and compliant regarding safety procedures, policies, permits, practices, PPE, and awareness. Initiates and leads accident, near miss reviews and incident notifications. Ensures proper housekeeping procedures are maintained.Quality - Responsible for team’s compliance and meeting the quality standards as defined by Integra’s SOPs, GMPs, Global Quality Standards, local and procedures, where applicable.  Plays an active role in Root Cause Analyses and in the resolution of Deviation, Non-Conformances, CAPAs, and Change Controls.  Plays an active role in developing validation plans/protocols, execution of those protocols, and closure of all compliance documentation.Manage People Effectively - Responsible for managing cross-functional staffs, training and daily reliability operations spanning all operational shifts.  Also interviews job candidates, completes performance reviews, and justifies promotions or disciplinary actions (as appropriate).Reliability Excellence -Takes a holistic approach to Reliability Centered Maintenance (RCM) and Asset Life Cycle Management of process and facilities equipment inclusive of all parts and demands.  The goal is to ensure that Integra LifeSciences’ equipment and facilities remain within their validated states and in a state of continuous inspectional readiness.Collaborates with broad multidisciplinary teams in the identification, quantification, elucidation of key objectives, assignment of responsibilities, change management, relevant protocols, protocol execution, collection of data, analysis, recommendations, final reports, final approvals, and regulatory submissions, where appropriate.Applies Best Engineering Practices to address the key objectives and provide impact statements to budgets, quality, regulatory compliance, and supply chain.Apply optimization efforts to maximize equipment uptime, yields, sustainability, conservation of critical utilities, consumption of supplies, Asset Life Cycle Management, reduction of waste, and 6S initiatives.Implement statistics-based metrics to define baselines and to quantify the results of reliability optimization efforts.  Partners with Cost Accounting to report bottom-line impact.Partner with Project Engineering in the User Requirement Specifications planning of new, repaired, restored, and/or replaced equipment/facilities.Prepares budgets, timelines, and collaborative requirements for reliability enhancement projects.Actively provides leadership and participates in cross-functional groups addressing Root Cause Analysis, Deviations, Non-Conformances, CAPAs, and Change Controls.Supports and encourages utilization of automated systems in new equipment/process delivery and existing processes.Provide technical coaching, professional mentoring, training, and career support for all stakeholders pursuing an engineering or management career path; prepare succession management plans for key positions identified in the department.Responsible for safety culture, awareness, and accountability within the multidisciplinary teams.

DESIRED MINIMUM QUALIFICATIONS

Bachelor's degree or higher in Engineering or relevant technical science required.Demonstrated statistical quality and optimization methods.Six Sigma certification is preferred (Black Belt or higher) with demonstrated reliability and economic enhancements.Lean certification is preferred.5+ years of reliability centered maintenance experience in the FDA regulated industries.Knowledgeable in various off-the-shelf software applications (MS Office, MS Project, AutoCAD) and customized systems (JMP/®Minitab®/R/SAS®/Excel StatPak, CMMS)Knowledgeable in setting and following budgets and timelines.Demonstrated abilities to enhance staff talent and careers through mentorship and training.Ability to communicate effectively at all levels (both oral and written) both to in-house and external officials, where required.Medical device reliability preferred.Demonstrated ability to provide high-level customer service.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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