Job DescriptionPosition SummaryThe 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 ResponsibilitiesManufacturing 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 CompetenciesTechnical 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
