Manager, Maintenance and Facilities Engineering at ICU Medical, Inc. in Dublin, Ohio

Job Description:

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 process engineering 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 improvements for quality improvements and cost reduction.
• Provides leadership guidance and supervision to department employees. Reviews performance and directs work accordingly.
• Supervises employees and contractors that construct, maintain and repair utility systems, building grounds, and equipment.
• Partner with HSE in developing and implementing safety related training/ procedures including Lockout/Tagout.
• Responsible for managing the CMMS software for corrective and preventative maintenance.
• Work with Manufacturing and Maintenance personnel to improve performance of manufacturing systems, e.g. yield improvements, scrap reduction, MUV reduction, cycle-time improvements, personnel requirements, ergonomic issues and maintenance needs.
• Coordinate efforts with the Materials Group to assess and prioritize material obsolescence projects.

Knowledge, Skills & Qualifications

• Knowledge of SolidWorks and experience with ASME Y14.5, ISO, and GD&T standards
• Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.) - Six Sigma Green Belt desired.
• Lean Methodology to improve production efficiency (equipment and processing improvements)
• Maintain thorough understanding of the clinical use of the product and clinical risk associated with the device
• Very strong experience managing people. Ability to mentor and hold people responsible.
• Thorough understanding of strength of materials, kinematics and dynamics, vibration, fluid flow as well as automation, plastic injection molding, part assembly, fixturing, testing, and process control techniques
• 
  Knowledge of /experience within regulated industry, Medical Device Industry preferred. Familiarity with FDA, QSR/ISO 9000/ISO 13485 and OSHA regulations
  

Education and Experience

• Must be 18 years of age
• Bachelor's degree in Engineering or Technology is required. MS or MBA is highly desired
• 
  Medical Device experience is desired. Process and Automation experience-engineering.
  
• 5 years of management experience is required
• 
  10 years' experience in the Medical Device, Regulated Industry or Engineering Industry in a high-speed production environment
  
• Advanced Degree may substitute for experience

Physical Requirements and Work Environment

• While performing the duties of this job, the employee is regularly required to talk or hear.
• This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines
• Work is performed in a clean room environment
• While performing the duties of this job, the employee may be required to sit or stand for long periods of time
• Must be able to occasionally move and lift objects of up to 25 lbs
• Typically requires travel less than 5% of the time

About Us



ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.

With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.

We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:

• Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
• The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
• IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
• Significant US IV solutions manufacturing and supply capabilities.

ICU Medical EEO Statement:


ICU Medical is committed to fostering a diverse, inclusive, and equitable work environment. As an Affirmative Action and Equal Opportunity Employer, we ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender identity, gender expression, gender reassignment, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.

ICU Medical EEO Policy Statement


OFCCP Equal Opportunity Posters

• "Know Your Rights" Poster
• Pay Transparency Nondiscrimination Provision

ICU Medical CCPA Notice to Job Applicants Apply Now