Operations Specialist

EndoSound is an early-stage medical device company that has developed the EndoSound Vision System (EVS), which converts upper GI endoscopes into a fully functioning endoscopic ultrasound (EUS) scope at a fraction of the cost of traditional systems.

We are an FDA-cleared designer and manufacturer, launching our systems for world-wide deployment. Our business model includes outsourcing and extensive utilization of external global resources and have built a small team of highly-competent individuals to manage our growth. We seek extraordinary people to help us manage this growth; each person is a key contributor and has the opportunity to grow and significantly influence our success, and we are looking for individuals who can grow with the company.

For this position we are seeking a competent generalist with basic experience and a can-do attitude, and we’ll train and help you grow into the more advanced aspects of the job. It’s an extraordinary chance to work with a top-notch team and build experience and a skill set across the wide range of operational areas.

Job Title: Operations Specialist. Location: Portland, OR; Employment Type: Regular Full-time; Work Model: 3 days on-site/Hybrid

Role summary: The Operations Specialist supports day-to-day production, supply chain, Quality, and fulfillment activities to ensure safe, compliant, and on-time delivery of medical devices. This role coordinates across Manufacturing, Quality, Supply Chain, and Customer Operations to manage work orders, materials, documentation, and logistics in accordance with FDA QSR (21 CFR Part 820), ISO 13485, and applicable regulations.

Key responsibilities

Production planning and execution

• Maintain accurate BOMs and routings in the ERP/MRP system.
• Coordinate daily production priorities, resolve material or documentation holds, and track WIP to meet OTIF (on-time in-full) targets.
• Support line changeovers, kitting, labeling, and device packaging.
• Maintain Device History Records (DHRs) and ensure Good Documentation Practices (GDP).

Supply chain and inventory management

• Plan and execute material purchases; monitor supplier delivery and quality performance.
• Perform receiving transactions, lot control, and traceability; coordinate receiving inspection with QA.
• Conduct cycle counts and root-cause inventory discrepancies; drive inventory accuracy and minimize obsolescence/scrap.
• Manage consigned and CMO/3PL inventories as applicable.

Quality and compliance

• Operate within ISO 13485, FDA requirements.
• Support nonconformance (NCMR), returned materials (RMA), deviation, and CAPA processes; implement containment and corrective actions.
• Execute change control (ECOs), including labeling and documentation updates; help maintain DMR and related records.
• Prepare for and participate in internal/external audits; ensure readiness of records, logbooks, and training.

Logistics and order fulfillment

• Plan and book domestic/international shipments (parcel, LTL), ensuring regulatory and trade compliance.
• Monitor order status, resolve holds, and collaborate with Customer Service to meet service levels.

Data, systems, and reporting

• Maintain accurate ERP/MRP transactions and dashboards
• Analyze basic KPIs and drive actions.
• Standardize work instructions/SOPs and support training for operators and cross-functional partners.
• (Growth area) Ensure Part 11-compliant electronic records where applicable.
• (Growth area) Implement and monitor advanced KPIs such as OTIF, OEE, inventory accuracy, cycle count variance, supplier OTD/quality/scrap

Continuous improvement and cross-functional support

• (Growth area) Apply Lean/Six Sigma tools to reduce waste, improve flow, and stabilize processes.
• (Growth area) Support tech transfers, new product introductions, and engineering pilots; ensure readiness of materials, tooling, and documentation.
• (Growth area) Partner with EHS to maintain safe work practices and support 5S/visual management.

Qualifications

• 3 years of a combination of operations/supply chain/quality/production experience in a regulated manufacturing environment; medical devices preferred.
• Hands-on ERP/MRP experience and strong Excel/Google Sheets skills.
• Proven experience with work orders, BOMs, inventory control, and lot/serial traceability.
• Understanding of NCMR/CAPA, change control (ECO), DMR/DHR, labeling/UDI, and basic supplier management.
• Excellent organization, communication, and problem-solving skills; comfortable in a fast-paced, cross-functional setting.
• Working knowledge of FDA 21 CFR 820, ISO 13485, and GDP preferred.
• Basic data skills and experience documenting SOPs/Work Instructions preferred.
• Experience supporting audits (FDA or other) and remediation activities a bonus.
• Experience with CMOs/3PLs a bonus.
• APICS/ASCM CPIM or CSCP, or Lean/Six Sigma certification ideal.

Tools and systems you may use

• ERP/MRP: [e.g. Netsuite]
• QMS/Document Control: [e.g., Greenlight Guru]
• CRM: [e.g. Salesforce]
• Collaboration: Microsoft 365/Google Workspace, project management tools

Work conditions

• Schedule: M-F, Standard hours with flexibility; occasional overtime during peaks or launches.
• (Growth area) Travel: 0–10% to suppliers, CMOs, or distribution centers as needed.
• Physical requirements: Ability to stand/walk on the production floor, lift up to 25–50 lbs occasionally, and handle repetitive tasks with appropriate PPE.

EndoSound is an equal opportunity employer. All employment-related decisions are based solely upon one’s individual merit and qualifications directly related to professional competence, and without regard to race, color, religion, national origin, pregnancy status, sex (gender}, age, marital status, mental or physical disability, sexual orientation, gender identity, military or veteran status, genetic history, or any other characteristic or classification protected by applicable law. We will also attempt to reasonably accommodate an individual based on his/her physical or mental limitation or because of the individual’s sincerely held religious beliefs.

How to apply: Please submit your resume and a brief note about your experience to info@endosound.com

Pay: $60,000.00 - $80,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• On-the-job training
• Paid time off
• Vision insurance

Work Location: Hybrid remote in Portland, OR 97239

Salary : $60,000 - $80,000