Manufacturing Operations Manager | Medical Device

Phoenix VX; Georgia; On-site; USD 125,000 - 145,000; Full time

Benefits offered by this job

Company-paid medical premiums for员工及家属

401(k) with company match

Relocation assistance may be available

Paid time off and holidays

Job summary

Phoenix VX is seeking an experienced Operations Manager / Production Manager to lead manufacturing operations in a highly regulated environment. You will drive safety, quality, and performance while developing supervisors and delivering the annual manufacturing plan.

The role requires hands-on leadership of a 50+ employee organization, with strong emphasis on regulatory compliance, production planning, and cross-functional collaboration across Quality, Supply Chain, Engineering, and EH&S.

Qualifications

• Hands-on manufacturing leadership experience in a regulated environment.
• Experience leading 50+ production employees through frontline leaders.
• Strong knowledge of production planning, capacity planning, labor scheduling, and MES/MIS systems.
• Familiarity with FDA, MDR, ISO, cGMP, TÜV, and OSHA requirements.

Responsibilities

• Lead daily manufacturing and production operations to meet safety, quality, delivery, productivity, and cost targets.
• Develop and execute production plans aligning labor, equipment, materials, capacity, and schedules.
• Lead an organization of ~50–55 employees with direct reports and frontline supervisors.
• Coach and develop production supervisors and emerging leaders to strengthen accountability.
• Ensure operations meet FDA/MDR/cGMP/quality-system requirements and manage regulatory risk.

Skills

Hands-on leadership

Production planning

Regulatory compliance

Leadership coaching

Cross-functional collaboration

Root cause analysis

Lean/Six Sigma

Budgeting

Equipment knowledge

Safety

Education

Bachelor's degree in Engineering/Manufacturing/Operations Management

Job description

Our client is seeking an experienced Operations Manager / Production Manager to lead manufacturing operations within a highly regulated production environment. This is a key site leadership position responsible for production performance, workforce leadership, production planning, regulatory compliance, and the execution of the annual manufacturing plan.

The ideal candidate is a hands-on manufacturing leader who combines strong technical and operational knowledge with the ability to develop supervisors, build accountability, and drive performance across a production organization of approximately 50+ employees.

Medical device manufacturing experience is strongly preferred, particularly experience operating under FDA, MDR, ISO, cGMP, and/or TÜV requirements. Candidates from similarly regulated manufacturing environments may also be considered based on the strength of their production leadership and demonstrated ability to successfully learn and operate within new regulatory frameworks.

KEY RESPONSIBILITIES

• Lead day-to-day manufacturing and production operations, ensuring achievement of safety, quality, delivery, productivity, and cost objectives.
• Develop and execute production plans by aligning labor, equipment, materials, capacity, and production schedules with site requirements and customer demand.
• Lead an operations organization of approximately 50-55 employees, including approximately five direct reports and frontline production leadership.
• Coach, mentor, and develop production supervisors, technical specialists, and emerging leaders, strengthening accountability and overall team performance.
• Establish clear performance expectations and provide consistent performance management, feedback, and employee development.
• Partner closely with Quality, Supply Chain, Engineering, Technical Services, Maintenance, Procurement, Finance, EH&S, and Training to ensure successful execution of production plans.
• Maintain production operations in accordance with applicable FDA, MDR, cGMP, OSHA, EH&S, and quality-system requirements.
• Support regulatory and quality compliance by identifying operational risks and ensuring manufacturing activities are executed within established procedures and controls.
• Monitor production performance through KPIs and operational metrics, identifying opportunities to improve throughput, efficiency, quality, labor utilization, and cost.
• Lead structured problem-solving and root cause analysis, supporting corrective and preventive actions when production or quality performance does not meet expectations.
• Drive continuous improvement and operational excellence initiatives across manufacturing operations.
• Coordinate resources and cross-functional support for strategic production improvements, equipment upgrades, process enhancements, and operational projects.
• Provide production and resource-planning input into budgeting, forecasting, and expense-management activities.
• Develop and manage operational plans involving resource, time, labor, equipment, and material allocation.
• Work effectively across organizational boundaries and build alignment among internal teams, vendors, contractors, engineering resources, and other stakeholders.
• Manage multiple operational priorities and projects simultaneously while maintaining production commitments and regulatory compliance.
• Foster a manufacturing culture centered on safety, quality, accountability, teamwork, employee engagement, and continuous improvement.

MINIMUM QUALIFICATIONS

• Bachelor's degree in Engineering, Manufacturing, Operations Management, or a related technical discipline preferred. Equivalent extensive manufacturing experience may be considered.
• 10+ years of progressive manufacturing and operations leadership experience within a regulated production environment.
• Medical device manufacturing experience strongly preferred.
• Demonstrated experience leading sizable manufacturing organizations, ideally 50+ production employees through frontline supervisors or other production leaders.
• Strong working knowledge of regulated manufacturing requirements, preferably including FDA and MDR regulations applicable to medical device manufacturing.
• Experience working within TÜV and/or ISO-regulated quality systems is highly desirable.
• Pharmaceutical or other highly regulated manufacturing experience may be considered, particularly when combined with demonstrated success learning and implementing new regulatory requirements.
• Strong knowledge of production planning, capacity planning, labor scheduling, resource allocation, and manufacturing execution.
• Demonstrated ability to balance safety, quality, delivery, productivity, and cost in a production environment.
• Strong understanding of engineering and manufacturing principles associated with the operation and maintenance of mechanical and electrical production equipment.
• Experience developing and managing operational or expense budgets and contributing to production forecasting and capital planning.
• Demonstrated success coaching and developing frontline supervisors and production leadership teams.
• Experience applying structured problem-solving, root cause analysis, CAPA, Lean Manufacturing, Six Sigma, or comparable continuous improvement methodologies.
• Strong analytical, organizational, communication, and decision-making capabilities.
• Ability to influence and collaborate effectively across multiple functions and organizational levels.

PREFERRED BACKGROUND

Candidates with direct experience in medical device manufacturing will receive strongest consideration, particularly those with exposure to:

• FDA-regulated medical device production
• Medical Device Regulation (MDR)
• TÜV-regulated environments
• ISO-based quality management systems
• cGMP manufacturing
• Production planning and manufacturing execution
• High-volume or complex manufacturing operations
• Continuous improvement and operational excellence

Candidates from pharmaceutical manufacturing or other similarly regulated industries may also align well when they bring substantial production leadership experience and a demonstrated ability to quickly learn and successfully operate within new regulatory and quality systems.

This position offers a highly competitive total rewards package, including:

• Base salary of $125,000-$145,000
• 17% target annual bonus
• Company-paid medical premiums for employees and eligible dependents
• 100% company match on the employee's first 4% 401(k) contribution, subject to plan eligibility requirements
• Dental and vision coverage
• Financial wellness resources
• Paid time off and company holidays
• Company shutdown periods
• Relocation assistance may be available based on individual circumstances

WHY CONSIDER THIS OPPORTUNITY?

This is an opportunity to take ownership of a substantial manufacturing operation while having a meaningful impact on production strategy, people development, operational performance, and continuous improvement.

The position offers significant visibility across the site and works directly with senior leadership and cross-functional partners. For an operations leader who enjoys being close to manufacturing, developing frontline leadership, solving complex production challenges, and improving how an organization executes, this role offers the opportunity to make a measurable impact.

This location provides access to a family-oriented community with outdoor recreation, parks, and a lower-cost lifestyle than many larger metropolitan areas.