Operations Manager

About the role

• The Operations Manager is responsible for overseeing and coordinating the day-to-day operational functions of EMED Technologies, including supply chain execution, contract manufacturing oversight, logistics, and cross-functional process improvement.
• This role serves as a central point of coordination between manufacturing, quality, regulatory, finance, and commercial teams to ensure operational continuity and scalability across EMED's US and international markets.
• The position reports directly to the Chief Operating Officer, with cross-functional reporting to the VP of Manufacturing and the Director of Sales and Marketing as applicable.

What you'll do

• Manage day-to-day operational workflows across supply chain, manufacturing coordination, distribution logistics, and customer fulfillment to ensure product availability and on-time delivery.
• Serve as the primary operational liaison with contract manufacturers and third-party logistics partners, monitoring performance against quality standards, lead times, and contractual obligations.
• Support coordination with EMED's Mexico manufacturing operations on production schedules, capacity planning, and compliance with applicable regulatory standards including NOM-241 and ISO 13485.
• Administer and optimize ERP, invoicing, and operational management platforms to ensure accurate inventory data, procurement records, and reporting; lead continuous improvement initiatives to enhance system utilization.
• Develop and present operational KPIs to leadership on a recurring basis, providing clear visibility into supply chain health, production performance, and fulfillment metrics.
• Coordinate with Quality and Regulatory Affairs to support nonconformance investigations, CAPA execution, supplier qualifications, and audit readiness from an operational standpoint.
• Partner with Finance to reconcile procurement and logistics costs, support budget tracking for operational spend, and contribute to annual planning processes.
• Support Sales and Marketing with order management, fulfillment execution, and customer-facing operational processes to ensure commercial commitments are met.
• Lead or support new product introduction (NPI) activities from an operations perspective, including component sourcing, supplier onboarding, and production readiness reviews.
• Identify and implement process improvements across the operations function, applying lean principles to reduce waste, shorten lead times, and improve cross-functional efficiency.
• Support international distribution activities across the EU, Japan, and other markets, coordinating with regional partners on order management, documentation, and regulatory shipment requirements.

Qualifications

• Bachelor's degree in Operations Management, Supply Chain Management, Business Administration, Engineering, or a related field.
• 3+ years of experience in operations, supply chain, or manufacturing management, preferably within the medical device or life sciences industry.
• Working knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, and EU MDR operational requirements; experience in a regulated manufacturing environment strongly preferred.
• Demonstrated experience managing contract manufacturers and third-party suppliers across multiple geographies.
• Proficiency with ERP, invoicing, and supply chain management systems; strong Microsoft Excel skills required.
• Exceptional organizational ability with a track record of managing multiple concurrent priorities in a fast-paced, lean-team environment.
• Strong analytical and problem-solving skills with the ability to synthesize operational data into actionable recommendations for leadership.
• Excellent written and verbal communication skills; comfortable interfacing with internal teams, external partners, and senior leadership.
• Ability to work independently, exercise sound judgment under ambiguity, and drive issues to resolution with minimal supervision.