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Director of Operations

L7

revmedxPortland, MEtoday

$145,000 per year

Occupations

General and Operations ManagersIndustrial Production ManagersFirst-Line Supervisors of Production and Operating Workers

Industries

Surgical Appliance and Supplies ManufacturingSurgical and Medical Instrument ManufacturingElectromedical and Electrotherapeutic Apparatus Manufacturing
RevMedx, Inc. develops and manufactures life-saving trauma care products for military and civilian medicine. Our portfolio includes XSTAT ® hemorrhage control devices, XGAUZE ® trauma dressing, and AirWrap ® bandages, with additional wound care products in development. We are a small, mission-driven team in Wilsonville, Oregon, operating under a 21 CFR 820/ISO 13485 quality system.
The Opportunity: We are hiring a Director of Operations to lead operations across our product lines as we grow. As Director of Operations, you will run the operations function, including production, contract manufacturers, supply chain, facilities, equipment and outside service providers, for our current products, new product introductions, and a multi-year expansion of XSTAT production under a government-supported program. This is a hands-on leadership role with real ownership and visible impact.
What you Will Do:
  • Lead operations strategy and execution across RevMedx’s product lines, with accountability for cost, schedule, output and on-time delivery to customers.
  • Lead the planned scale-up of XSTAT production from current output to full-rate manufacturing across our Wilsonville facility and a qualified contract manufacturer as part of lifecycle management.
  • Support new product introductions, including manufacturing transfer and production readiness for products in development.
  • Select and manage contract manufacturers, including the day-to-day working relationship, generating manufacturing agreement(s), performance reviews and capacity planning.
  • Support Quality in the qualification and annual requalification of new and existing suppliers and contract manufacturers.
  • Direct production readiness in partnership with Engineering and Quality: site qualification, equipment procurement, installation and qualification (IQ/OQ/PQ), pilot builds and the transition to full-rate production.
  • Build a resilient supply base, including qualification of second sources for critical materials and components.
  • Own production planning, purchasing, inventory and material flow to meet military, government and commercial customer demand. Put forecasting, sales, and operations planning in place.
  • Lead and grow the operations team, including planning and purchasing, production supervision and manufacturing technicians; hire, train and develop staff.
  • Partner with Regulatory Affairs/Quality Assurance so operations comply with FDA 21 CFR Part 820 and ISO 13485. Quality owns the quality system; you lead a compliant, well-documented operation.
  • Establish operating metrics (output, yield, on-time delivery, cost) and drive continuous improvement using risk management and lean methods
  • Direct and be responsible for worksite and operations safety, including safety programs, hazard assessment, training, incident follow-up and compliance with Oregon OSHA requirements.
  • Manage company facilities, including space planning, building services, landlord and vendor relationships, and an organized and efficient production environment.
  • Own the operations layout: plan production areas, workstations and material flow, and lead facility changes such as installing a controlled-environment production area.
  • Run equipment purchasing and the equipment maintenance program, including specification, vendor selection, installation, preventive maintenance and calibration, in coordination with Engineering and Quality.
  • Oversee information technology and systems (IT/IS) through RevMedx’s outside providers: manage service providers, priorities and costs, and coordinate business systems that support operations. Hands-on IT skills are not required.
  • What you Bring
  • Bachelor’s degree in engineering, operations management, supply chain or a related field.10 or more years in manufacturing operations, including at least 5 years leading production or operations teams.
  • Experience in medical device manufacturing or another FDA- or ISO-regulated production environment.
  • A track record of scaling production or transferring manufacturing to a new site or contract manufacturer.
  • Working knowledge of equipment qualification, process validation, change control and supplier controls.
  • Experience with production planning, purchasing and inventory systems (ERP/MRP).Strong communication skills: you can lead cross-functional teams, manage suppliers and partners, and report clearly to executives.
  • Experience leading workplace safety programs in a manufacturing environment.
  • Comfort in a small company: hands-on, organized and willing to work on the production floor.
Nice To Have: MBA or other advanced degree. Experience with sewn, assembled or sterile-packaged single-use devices. Lean or Six Sigma certification. Experience using an electronic quality management system (eQMS) and assisting Quality in the implementation and maintenance of the system, as needed. Experience managing facilities, production layouts or equipment maintenance programs. Experience managing outsourced IT or other service providers.
Compensation and Benefits: Base salary of $145,000 to $175,000 per year, depending on experience and qualifications. Eligibility for performance-based bonuses tied to company and individual results. Potential participation in a planned employee stock option program. Health insurance. Location and Travel This is an in-person role at our Wilsonville, Oregon facility, with travel of up to about 20% to our contract manufacturer and suppliers. RevMedx is an equal opportunity employer. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status or any other characteristic protected by law.
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Level

ManagerL7

Salary

$145,000 per year

Location

Portland, ME

Occupation

General and Operations Managers

Industry

Surgical Appliance and Supplies Manufacturing

Posted

today

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