Manager, Engineering

Position Summary

The Manager, Engineering, provides strategic leadership and technical direction to ensure the development and execution of efficient, effective manufacturing methods that support the production of high-quality medical devices. This role is responsible for ensuring compliance with engineering specifications, FDA regulations, GMP requirements, and company quality standards. The Manager will lead a team of engineering professionals while driving key initiatives related to process optimization, production scale-up, automation, and high-volume manufacturing.

The ideal candidate is a hands-on engineering leader with deep expertise in medical device manufacturing, injection molding, automation, continuous improvement, and team development.

This role is 100% onsite at our Dublin, OH manufacturing facility.

Essential Duties and Responsibilities

Manufacturing Support & Operational Excellence

• Provide technical leadership to support ongoing manufacturing operations and ensure production continuity.
• Lead root cause investigations for non-conformances and implement sustainable corrective and preventive actions (CAPA).
• Identify and resolve systemic manufacturing issues impacting safety, quality, delivery, or cost.
• Collaborate with Manufacturing and Maintenance teams to improve equipment reliability, process capability, yield performance, cycle times, scrap reduction, material usage variance (MUV), and ergonomics.
• Drive operational improvements that enhance manufacturing efficiency and overall equipment effectiveness (OEE).

Continuous Improvement & Process Engineering

• Champion Lean Manufacturing and Six Sigma initiatives to improve productivity, quality, and cost performance.
• Analyze production processes and identify opportunities for waste reduction, process optimization, and automation.
• Assess yield and quality issues and develop solutions that improve process capability and product performance.
• Evaluate, recommend, and implement new manufacturing technologies, equipment, tooling, and automation systems.
• Lead continuous improvement efforts that support scalable, high-volume manufacturing operations.

Engineering Leadership & People Management

• Directly manage, mentor, and develop a team of engineers and technical staff.
• Establish priorities and allocate resources based on business objectives and organizational needs.
• Provide coaching, performance feedback, and professional development opportunities for team members.
• Foster a culture of accountability, collaboration, innovation, and continuous improvement.
• Promote attainment of organizational objectives through effective leadership and employee engagement.

Project & Program Management

• Lead multiple engineering projects simultaneously from concept through implementation.
• Develop project plans, timelines, resource requirements, budgets, and key milestones.
• Conduct project and team meetings to monitor progress, communicate updates, and resolve obstacles.
• Coordinate cross-functional activities to ensure projects are completed on time and within budget.
• Support strategic initiatives including capacity expansion, process transfers, automation projects, and new product introductions.

Technical Engineering Leadership

• Provide technical guidance and decision-making for complex, non-routine engineering challenges.
• Apply advanced engineering principles and independent judgment to evaluate and implement solutions.
• Support design reviews, process development, equipment selection, tooling improvements, and validation activities.
• Serve as a technical resource for manufacturing, quality, maintenance, and senior leadership teams.

Cross-Functional Collaboration

• Partner with Manufacturing, Quality, Maintenance, Supply Chain, Regulatory Affairs, and other departments to achieve organizational objectives.
• Collaborate with suppliers and external partners to secure resources, troubleshoot technical issues, and support project execution.
• Facilitate communication and alignment across departments to support business priorities and manufacturing goals.

Documentation, Validation & Regulatory Compliance

• Oversee preparation, review, and approval of engineering documentation, including drawings, schematics, validations, capability studies, and standard operating procedures.
• Ensure compliance with engineering specifications, quality system requirements, FDA regulations, GMP standards, and applicable industry regulations.
• Prepare reports, metrics, presentations, and technical documentation for leadership and audit purposes.
• Support internal and external audits and ensure timely closure of engineering-related findings.

Strategic Leadership

• Support company strategic initiatives and operational goals through engineering excellence.
• Identify opportunities to improve manufacturing scalability, cost competitiveness, and operational performance.
• Model company values and promote a culture of continuous improvement and customer focus.

Environmental, Health & Safety (EHS)

• Ensure compliance with all applicable environmental, health, and safety regulations and company policies.
• Actively promote and participate in EHS programs and initiatives.
• Champion a safe work environment and drive continuous improvements in workplace safety and environmental performance.

Knowledge, Skills, and Competencies

Technical Expertise

• Strong working knowledge of Six Sigma methodologies, including DOE, Process Capability Analysis, Gage R&R, Statistical Process Control (SPC), and process validation techniques.
• Proven experience implementing Lean Manufacturing principles to improve operational performance and eliminate waste.
• Proficiency in SolidWorks and a strong understanding of ASME Y14.5, ISO standards, and GD&T principles.
• Thorough understanding of medical device manufacturing processes and quality systems.
• Comprehensive knowledge of:
• Plastic injection molding
• Tooling design and maintenance
• Automation systems
• Assembly processes
• Fixturing and testing systems
• Process controls
• Strength of materials
• Kinematics and dynamics
• Vibration analysis
• Fluid flow principles

Leadership Competencies

• Strong people leadership and team development skills.
• Ability to lead and influence cross-functional teams.
• Effective project management and organizational skills.
• Strong business acumen and strategic thinking abilities.
• Excellent verbal, written, and presentation communication skills.

Problem Solving

• Demonstrated ability to analyze complex manufacturing and engineering issues and implement sustainable solutions.
• Exceptional root cause analysis, troubleshooting, and decision-making capabilities.

Education and Experience:

• Must be 18 years of age.
• Bachelor's degree in engineering, Engineering Technology, or a related technical field required.
• Master's degree (MS) and/or MBA preferred.
• Minimum of 5 years of engineering experience including leadership experience in the medical device industry or a similarly regulated manufacturing environment.
• Demonstrated expertise in injection molding, tooling, automation, and manufacturing process development.
• Experience supporting FDA-regulated manufacturing environments and quality systems.

Physical Requirements and Work Environment

• Work is performed in both office and manufacturing environments, including cleanroom settings.
• Frequent use of computers, telephones, and standard office equipment.
• Regular interaction with employees, vendors, customers, and cross-functional teams.
• Must be able to sit, stand, walk, and move throughout manufacturing and office areas for extended periods.
• Occasionally required to lift and move objects weighing up to 25 pounds.
• Typically requires travel less than 10% of the time

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 being an 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, 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

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