General Manager

Aptyx • Olympic Woods, NC

15d • Hybrid

About The Position

The General Manager is responsible for the overall leadership and performance of Aptyx's Charlotte operation, specializing in the development and manufacture of interventional medical technologies. This role provides strategic and operational oversight across Research & Development, Program Management, Quality, Manufacturing, Supply Chain, and supporting functions to ensure the successful development, commercialization, and delivery of innovative medical solutions. With full accountability for business results, the General Manager drives growth, operational excellence, customer satisfaction, and employee engagement while ensuring compliance within a highly regulated, ISO 13485-certified environment. This leader fosters a culture of innovation, accountability, and continuous improvement to advance Aptyx's position as a trusted partner in the interventional medical device market. The ideal candidate brings a strong technical and operational background within the medical device industry, with experience leading organizations that span both R&D and regulated manufacturing environments, including ISO 13485-certified clean room operations.

Requirements

• Bachelor's degree in Engineering, Operations Management, Business Administration, or a related discipline required.
• Minimum of 10 years of progressive leadership experience within the medical device industry.
• Minimum of 5 years of experience in a senior operations leadership role with direct P&L accountability.
• Demonstrated success leading organizations that integrate R&D and regulated manufacturing operations.
• Experience within ISO 13485-certified and FDA-regulated environments required.
• Previous experience leading clean room manufacturing operations required.
• Strong understanding of medical device development processes, design transfer, validation, and commercialization.
• Knowledge of FDA Quality System Regulations, ISO 13485, risk management principles, and design control requirements.
• Experience implementing Lean Manufacturing and continuous improvement methodologies.
• Familiarity with ERP systems, operational analytics, and performance management tools.

Nice To Haves

• Master's degree in Business Administration, Engineering Management, or a related field preferred.
• Experience supporting interventional medical devices, minimally invasive technologies, catheter-based products, or related markets strongly preferred.
• Lean Six Sigma Green Belt, Black Belt, or equivalent.
• Project Management Professional (PMP) certification.
• ASQ certifications are a plus.

Responsibilities

• Develop and execute the site's strategic plan in alignment with Aptyx's growth objectives and long-term business strategy.
• Lead the Charlotte operation as a Center of Excellence for interventional medical device development and manufacturing.
• Establish annual operating plans, budgets, capital strategies, and performance objectives.
• Drive achievement of key business metrics, including revenue growth, EBITDA, customer satisfaction, quality performance, on-time delivery, employee engagement, and safety performance.
• Serve as an active contributor to enterprise-wide initiatives and cross-site collaboration efforts.
• Provide leadership and oversight for all manufacturing operations, including clean room production, assembly, validation, and support functions.
• Ensure effective execution of production plans to meet customer commitments related to quality, delivery, and cost.
• Champion Lean Manufacturing principles and continuous improvement initiatives to increase productivity, reduce waste, and optimize resource utilization.
• Monitor operational performance through defined KPIs and implement corrective actions as necessary.
• Lead capacity planning activities to support business growth and new program launches.
• Partner with R&D leaders to accelerate innovation while ensuring design solutions are scalable and manufacturable.
• Support the successful transition of products from concept through development, validation, and commercialization.
• Facilitate strong collaboration between R&D, Engineering, Program Management, Quality, and Operations teams.
• Ensure development activities align with customer requirements, regulatory expectations, and business objectives.
• Foster a culture of innovation while maintaining disciplined execution and risk management.
• Build and maintain executive-level relationships with strategic customers within the interventional medical device market.
• Serve as the senior escalation point for customer concerns, ensuring timely resolution and sustained customer confidence.
• Participate in business development activities, customer visits, technical reviews, and operational presentations as appropriate.
• Support growth initiatives by identifying opportunities for expanded services, capabilities, and strategic partnerships.
• Promote a culture where quality and patient safety are foundational to all business activities.
• Ensure compliance with applicable regulations and standards, including ISO 13485, FDA Quality System Regulations, and customer-specific requirements.
• Support quality initiatives related to audits, CAPAs, complaint investigations, nonconformance management, and continuous improvement activities.
• Drive proactive risk management and robust quality planning throughout the organization.
• Assume full P&L responsibility for the Charlotte operation.
• Develop and manage annual budgets, forecasts, and capital expenditure plans.
• Monitor financial performance and implement strategies to improve profitability and operational efficiency.
• Evaluate investments, resource allocation decisions, and growth opportunities to maximize business performance.
• Drive cost management initiatives while protecting quality, delivery, and employee engagement.
• Build, develop, and retain a high-performing leadership team.
• Foster a culture aligned with Aptyx values of accountability, collaboration, innovation, and continuous improvement.
• Provide coaching and mentorship to functional leaders to strengthen leadership capability throughout the organization.
• Support succession planning and talent development initiatives to ensure organizational readiness for future growth.
• Champion employee engagement initiatives that promote inclusion, recognition, communication, and development.
• Ensure compliance with all applicable environmental, health, and safety regulations.
• Promote a proactive safety culture focused on prevention, accountability, and employee involvement.
• Support regular safety audits, risk assessments, and corrective action initiatives to maintain a safe workplace.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior