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 in medical devices or life sciences.
Knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, and EU MDR operational requirements; experience in regulated environments preferred.
Experience managing contract manufacturers and third-party suppliers across multiple regions.
Proficiency with ERP and supply chain management systems; strong Microsoft Excel skills required.
Exceptional organizational skills with a history of managing multiple priorities in a fast-paced environment.
Strong analytical and problem-solving skills to translate operational data into actionable insights.
Excellent communication skills for interfacing with teams, partners, and leadership.
Ability to work independently and resolve issues with minimal supervision.
Responsibilities
Manage daily operational workflows in supply chain, manufacturing, logistics, and customer fulfillment.
Serve as the primary liaison with contract manufacturers and logistics partners, ensuring quality and compliance.
Coordinate with Mexico manufacturing on production schedules and regulatory compliance.
Administer and optimize ERP and operational management platforms for accurate inventory and reporting.
Develop and present operational KPIs to leadership for visibility into supply chain and production performance.
Support Quality and Regulatory Affairs in investigations, CAPA execution, and audit readiness.
Partner with Finance to reconcile costs and support budget tracking for operational spending.
Support Sales and Marketing with order management and fulfillment processes.
Lead new product introduction activities from an operations perspective, including sourcing and production readiness.
Identify and implement process improvements using lean principles to enhance efficiency.
Support international distribution activities, coordinating with regional partners on compliance and documentation.
Benefits
Comprehensive health insurance plans.
Retirement savings plan with company match.
Flexible work hours and remote work options.
Professional development opportunities and training programs.
Generous paid time off and holiday schedule.
Full Job Description
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.
