Job Description Position Summary The Engineering, Maintenance & Facilities Manager provides leadership and technical support to ensure development of efficient and effective methods that support design, launch and production of medical devices with highest quality that are in compliance with engineering specifications, Food and Drug Administration (FDA) and Good Manufacturing Practices (GMP) guidelines. Also, define and specify the implementation of standards, methods, and procedures for testing, and evaluating the product to established standards. Must have strong product development, injection molding, tooling and automation background as well as Medical Device and manufacturing experience. This individual will provide leadership for multiple technical personnel and play a major role in projects that encompass; R&D concept, pilot production, intermediate production, production scale up and high-volume manufacturing. Essential Duties & Responsibilities * Supervise Engineers and Technicians and provide overall technical leadership * Manages directly the facilities and maintenance department, department coordination, capital projects and budget review * Support department in achieving business unit objectives and company goals * Identify business needs and recruit exceptional talent for the organization. * Identify strengths and opportunities in the team. Provide coaching, training and mentoring opportunities as applicable. * Provide direction and keep the team apprised of company policies, goals, and expectations. * Goal management and performance evaluation * Drive coalition and synergy in the team. Challenge team for innovation and change. * Drive optimal solutions with consensus from marketing and other ICU facilities. * Propose ideas; generate projects (business continuity, new product development, revenue, and quality improvement projects). Use of project management systems and resource availability assessment * Manage stakeholder expectations across the organization up to executive management * Generate timelines and milestones and bring project to completion on time and within budget * Prioritize projects based on the business needs and resources availability * Track and maintain up to date financial information for Projects * Ensures that preventative maintenance routines are executed on facilities and manufacturing equipment to maximize equipment performance and longevity. * Partner with regulatory to maintain up to date product information and maintain knowledge of upcoming regulation, current regulatory body and customer requests * Support marketing needs with respect to new product development, enhance existing products to fulfill unmet needs, and bring new level of excellence with the quality and design of the existing and new products). * Develop specifications and associated test methods with thorough understanding of industry standards, user and marketing requirements. * Support product development process with detail to user, manufacturing and sterilization requirements * Oversee product design qualifications, design history files and device master record development. * Support Regulatory department with technical filing and 510K approvals. * Provide technical support during clinical trials and product investigations. * Drive effective CAPA resolutions. * Support Production and ensure the continuity of manufacturing operations. Drive root cause analysis for nonconformance, long-term corrective actions, and preventative measures. Address systemic Issues. * Spearhead initiatives for continuous process and lean implementations: Assess yield issues and implement design/equipment i Apply here: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjM2MTI0LjEwNTA4QGljdW1lZGNvbXAuYXBsaXRyYWsuY29t