Manufacturing Engineering Manager

The Manufacturing Engineering Manager provides technical leadership and direction for the Manufacturing Engineering function at the Charlotte location. This position is designed for a highly experienced Senior or Principal Engineer who is ready to take the next step into leadership while remaining actively engaged in technical and project work.

The Manufacturing Engineering Manager leads and mentors the Manufacturing Engineering team in the successful transfer of products and processes from Product Development into production, as well as the continuous improvement of existing manufacturing processes, equipment, tooling, and methods.

This is a hands-on leadership role requiring strong technical expertise, sound project management, and the ability to work closely with Product Development, Engineering, Quality, Operations, and customers. The Manager will provide day-to-day direction to the Manufacturing Engineering team, remove obstacles, establish priorities, and ensure projects are delivered safely, efficiently, and in compliance with applicable medical device quality and regulatory requirements.

The successful candidate will serve as both a technical leader and people leader, helping develop the next generation of manufacturing engineers while maintaining direct involvement in complex transfers, process development, troubleshooting, validation, and production support.

Essential Duties and Responsibilities

Technical Leadership & Team Development

• Provide technical leadership, mentoring, and day-to-day direction to Manufacturing Engineering team members.

• Serve as a technical resource and escalation point for complex manufacturing engineering issues.

• Develop the skills and capabilities of the engineering team through coaching, mentoring, feedback, and hands-on support.

• Establish priorities, assign resources, and monitor progress across multiple projects and sustaining activities.

• Provide performance feedback and make staffing, development, and resource recommendations.

• Promote a culture of accountability, collaboration, problem-solving, and continuous improvement.

Product & Process Transfer

• Lead and support the transfer of products, processes, equipment, and manufacturing methods from Product Development into production.

• Partner with Product Development and Operations to ensure products are designed for manufacturability, scalability, quality, and cost effectiveness.

• Develop and execute manufacturing strategies for new product introductions and production launches.

• Identify manufacturing risks, resource requirements, technical gaps, and opportunities early in the development and transfer process.

• Guide engineering activities through design transfer, design control, design reviews, process development, and production readiness.

• Ensure appropriate manufacturing documentation, work instructions, equipment requirements, tooling, fixtures, and process controls are established prior to production launch.

Manufacturing Engineering & Process Improvement

• Lead improvements to existing manufacturing processes, equipment, tooling, fixtures, and methods to improve quality, throughput, efficiency, cost, and reliability.

• Provide hands-on troubleshooting and technical support for production issues and manufacturing challenges.

• Analyze production performance and develop project plans to address process inefficiencies, recurring problems, scrap, downtime, and other operational opportunities.

• Apply engineering principles, root cause analysis, Lean/Six Sigma methodologies, and data-driven problem solving to improve manufacturing performance.

• Evaluate process capability and identify opportunities for automation, equipment improvements, and technology implementation.

• Support cost-of-goods objectives through process optimization, productivity improvements, and effective use of manufacturing resources.

Validation & Quality

• Ensure Manufacturing Engineering activities comply with the company's Quality Management System and applicable medical device requirements.

• Lead and/or oversee process verification and validation activities, including protocols, reports, process capability studies, GR&R, and test method validation.

• Partner with Quality to establish appropriate inspection methods, gauges, equipment qualifications, and process controls.

• Support development of maintenance, calibration, and qualification requirements for project-specific equipment and tooling.

• Ensure engineering changes and process improvements are appropriately documented and implemented within applicable quality systems.

• Analyze technical and statistical data to support process decisions and demonstrate process capability.

Project Management

• Lead multiple projects of varying complexity from concept through implementation.

• Establish project timelines, milestones, deliverables, resources, and priorities.

• Identify resource constraints and coordinate support across Engineering, Product Development, Quality, Operations, Supply Chain, and other functional areas.

• Monitor project progress and communicate status, risks, resource needs, and key decisions to leadership and internal stakeholders.

• Ensure projects are completed on schedule and meet established technical, quality, cost, and customer requirements.

• Support preparation of quotations and technical estimates for new production opportunities and engineering projects.

Equipment, Tooling & Capital

• Evaluate manufacturing equipment, tooling, fixtures, and process technologies to support new and existing products.

• Partner with Operations and Product Development to determine equipment and tooling requirements.

• Develop technical recommendations and business justification for capital expenditures.

• Support equipment installation, qualification, implementation, and production readiness.

• Identify opportunities to improve manufacturing capability through automation and other advanced manufacturing technologies.

Production & Business Support

• Provide hands-on engineering support to Production to resolve technical issues and maintain reliable manufacturing processes.

• Partner with Operations to ensure manufacturing processes support customer requirements for quality, quantity, delivery, and cost.

• Support ERP systems and the creation and maintenance of appropriate manufacturing and inventory documentation.

• Establish and report Manufacturing Engineering performance metrics, project status, and key operational indicators.

• Communicate engineering priorities and project status effectively to leadership and cross-functional stakeholders.

Qualifications

• Strong background in medical device product development, manufacturing engineering, and/or design transfer.

• Demonstrated experience transferring products and processes from Product Development/R&D into production.

• Strong understanding of manufacturing processes, materials, tooling, equipment, and process development.

• Demonstrated ability to troubleshoot complex manufacturing and production issues.

• Strong project management skills with experience leading multiple complex projects simultaneously.

• Working knowledge of medical device quality systems and regulatory requirements.

• Experience with process validation, process capability, GR&R, statistical analysis, and test method validation.

• Experience working cross-functionally with Product Development/R&D, Quality, Operations, and customers.

• Six Sigma, Lean, or other continuous improvement certification preferred.

• Experience with automation or advanced manufacturing technologies preferred.

Education

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related engineering discipline required.

• Master's degree preferred.

Experience

• 7+ years of engineering experience, preferably within the medical device industry.

• Experience in medical device development, manufacturing engineering, and/or design transfer.

• Demonstrated experience leading complex engineering projects.

• Experience working in an FDA-regulated and ISO 13485 environment preferred.

• Experience mentoring or providing technical leadership to engineers strongly preferred.

• ERP experience preferred.

• Experience with SolidWorks or equivalent CAD software preferred.

Skills, Knowledge & Abilities

• Strong technical and analytical problem-solving skills.

• Hands-on approach with the ability to work directly with equipment, processes, tooling, and production teams.

• Strong understanding of product and process transfer from development to production.

• Ability to translate complex technical problems into practical manufacturing solutions.

• Strong project management and organizational skills.

• Ability to prioritize multiple projects and effectively allocate team resources.

• Excellent verbal and written communication skills.

• Ability to influence and collaborate effectively across functions and organizational levels.

• Strong coaching and mentoring skills.

• Proficiency with Microsoft Office or equivalent business applications.

• Ability to interpret engineering drawings, specifications, technical data, and statistical information.

• Working knowledge of SolidWorks or equivalent CAD software.

Leadership Competencies

• Technical Leadership – Uses technical expertise to guide decisions, solve complex problems, and raise the capability of the engineering team.

• Develops Others – Coaches and mentors engineers while creating opportunities for technical and professional growth.

• Collaboration – Builds strong partnerships across Product Development, Quality, Operations, and other functions.

• Accountability – Establishes clear expectations and follows through on commitments, timelines, and results.

• Problem Solving – Uses data, engineering principles, and structured problem-solving methods to identify root causes and implement sustainable solutions.

• Continuous Improvement – Challenges existing processes and identifies opportunities to improve quality, efficiency, cost, and scalability.

• Customer Focus – Ensures engineering decisions support customer requirements and successful product launches.

• Growth Mindset – Continuously develops technical expertise, embraces new technologies, and helps others grow.