Senior Operations Manager - Medical Device - Burlington, MA

Job Description

Lead daily manufacturing operations across internal production, contract manufacturing, production testing, depot repair, field asset management, and facilities.
Manage contract manufacturing relationships, ensuring schedule attainment, product quality, responsiveness, and delivery performance.
Develop and monitor KPIs related to safety, quality, delivery, productivity, inventory, and operational performance.
Drive operational excellence, continuous improvement, and Lean Manufacturing initiatives across the organization.
Establish scalable systems, processes, and governance to support business growth and operational efficiency.
Partner with Supply Chain, Engineering, Quality, Regulatory, Service, and R&D teams to support product launches, manufacturing transfers, and sustaining operations.
Ensure compliance with ISO 13485, FDA Quality System Regulations, MDSAP, EU MDR, and company quality system requirements.
Lead daily operational reviews, GEMBA walks, and cross-functional communication activities.
Support production readiness, material availability, customer requirements, and production schedule adherence.
Drive issue resolution and corrective actions related to manufacturing, quality, supplier, and operational challenges.
Analyze operational data and business metrics to support data-driven decision-making.
Develop and improve operational workflows, manufacturing efficiency, and resource utilization.
Support budget objectives, operational planning, and strategic initiatives in partnership with senior leadership.
Assist with product complaint investigations, trend analysis, and operational support activities when needed.
Provide hands-on leadership and support on the manufacturing floor to meet customer and business commitments.

Requirements

• Bachelor's degree in a technical, scientific, engineering, or related discipline.
• 5+ years of medical device manufacturing leadership experience.
• Experience managing operations within an ISO 13485-regulated environment.
• Strong knowledge of FDA Quality System Regulations, MDSAP, and medical device manufacturing requirements.
• Working knowledge of Design Controls, DHF, DMR, DHR, and CAPA processes.
• Experience leading contract manufacturing and supplier management activities.
• Strong background in Lean Manufacturing and continuous improvement methodologies.
• Experience with ERP systems such as NetSuite or similar platforms.
• Strong project management, communication, and leadership skills.
• Proven ability to drive results in fast-paced, highly regulated environments.
• Excellent analytical, organizational, and problem-solving abilities.
• Able to lead cross-functional teams within a matrixed organization.

Qualifications

• Hands-on leadership and support on the manufacturing floor.
• Collaborative leadership team and mission-driven culture.
• Opportunity to shape operational strategy and scalable manufacturing processes.
• Exposure to new product introductions, manufacturing transfers, and commercial growth initiatives.
• Competitive compensation and benefits package.

Benefits

High-impact leadership role within a growing medical device company.
Opportunity to shape operational strategy and scalable manufacturing processes.
Exposure to new product introductions, manufacturing transfers, and commercial growth initiatives.
Collaborative leadership team and mission-driven culture.
Strong career advancement potential.
Competitive compensation and benefits package.

Pay

TBD

Schedule

TBD