General Manager, Medical Device
Aequor
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Job summary
Aequor Charlotte operation leads development and manufacture of interventional medical technologies, providing strategic and operational oversight across R&D, program management, quality, manufacturing, and supply chain to ensure successful development and delivery.
The General Manager has full accountability for business results, drives growth and customer satisfaction, ensures compliance in ISO 13485 environments, and fosters innovation, accountability, and continuous improvement.
Qualifications
- Experience leading medical device operations.
- Knowledge of ISO 13485 and FDA regulations.
- Ability to lead cross-functional teams across R&D, quality, manufacturing, and supply chain.
Responsibilities
- Develop and execute the site strategic plan in alignment with growth objectives.
- Lead the Charlotte operation as a Center of Excellence for interventional medical device development and manufacturing.
- Establish annual operating plans, budgets, and capital strategies.
- Drive key metrics: revenue growth, EBITDA, on-time delivery, quality, and safety.
- Foster collaboration across R&D, engineering, program management, quality, and operations.
Skills
Education
Tools
Job description
The General Manager is responsible for the overall leadership and performance of companies 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 companies 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.
- Develop and execute the site's strategic plan in alignment with companies 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 company 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.
Develops and communicates a clear vision that aligns site priorities with companies business objectives. Anticipates industry trends, customer needs, and organizational challenges to position the business for long-term success. Balances strategic thinking with disciplined execution to achieve sustainable growth.
- Translating strategy into measurable operational objectives.
- Making decisions that balance short-term performance with long-term business needs.
- Identifying opportunities for innovation, market expansion, and capability enhancement.
Builds trusted relationships with customers by understanding their objectives, anticipating needs, and consistently delivering value. Acts as a strategic partner to support the successful development and commercialization of medical technologies.
- Promoting a customer-centric culture throughout the organization.
- Serving as an executive sponsor for key customer relationships.
- Driving responsiveness, transparency, and accountability in customer interactions.
Champions a culture of execution, accountability, and continuous improvement to achieve exceptional business results. Leverages data, industry best practices, and cross-functional collaboration to optimize quality, delivery, productivity, and profitability.
- Establishing clear performance expectations and monitoring outcomes through KPIs.
- Leading initiatives that improve efficiency, reduce waste, and strengthen organizational capability.
- Ensuring operational decisions prioritize quality, patient safety, and business performance..
- Bachelor's degree in Engineering, Operations Management, Business Administration, or a related discipline required.
- Master's degree in Business Administration, Engineering Management, or a related field preferred.
- 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 supporting interventional medical devices, minimally invasive technologies, catheter-based products, or related markets strongly preferred.
- Experience within ISO 13485-certified and FDA-regulated environments required.
- Previous experience leading clean room manufacturing operations required.
- Proven track record of driving operational improvements, organizational growth, and customer satisfaction.
- 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.
- Lean Six Sigma Green Belt, Black Belt, or equivalent.
- Project Management Professional (PMP) certification.
- ASQ certifications are a plus.
- Combination of office, laboratory, clean room, and manufacturing environments.
- Regular interaction with customers, suppliers, and cross-functional teams.
- Ability to travel domestically and internationally up to 25%, as business needs require.
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