Careers

Innovate. Execute. Create Value. 

EchoNous is a well-funded medical device startup in the Seattle, WA area. We are applying the emerging field of artificial intelligence (AI) with the extreme miniaturization of ultrasound to solve common everyday problems in healthcare. We are growing rapidly and have several open positions to join our multidisciplinary team.

If you are passionate about problem-solving and eager to work with world class innovators, please submit your resume to careers@echonous.com

We offer competitive salary with generous stock options, unlimited vacation, 401K, health insurance, H1-B sponsorship and free fitness center. EchoNous Inc. is an Equal Opportunity Employer.

Explore current opportunities below.

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Operator / Assembler

Primary Responsibilities:

  • Assemble small parts and components using custom tooling
  • Dispense and weigh epoxies, fillers and silicones using scales and cast into molds
  • Inspect small components under a microscope for defects or abnormalities
  • Work alongside Technicians and Engineers in the manufacturing group.
  • Build and test product subassemblies and final assemblies
  • Operate production equipment in accordance with standard operating procedures
  • Utilize Assembly Instructions to process ultrasound finished goods and subcomponents
  • Perform acceptance testing, continuity checks, and other “Pass or Fail” tests per documentation
  • Visually check work against drawings/work instructions to ensure high quality standards
  • Set up and properly utilize all applicable hardware, tools and fixtures to complete work assignments
  • Coordinate with Engineering to troubleshoot problems with equipment, devices, or products
  • Help implement and maintain LEAN initiatives including Visual Factory, 5S, and Continuous Improvement
  • Interpret and work in accordance with drawings, Assembly Instructions and other applicable engineering work Instructions or deviations

Qualifications and Skills:

  • Ability to read and understand production documentation, production planning information
  • Ability to work on a sustained basis within any physical and environmental requirements applicable to area of assignment, e.g., highly repetitive work, hot tools or materials, epoxy or other chemical agents, fumes, noise, oily or similar conditions
  • The ability to use hand or power tools such as torque wrenches and microscopes.
  • Excellent reading comprehension and verbal communication skills in the English language
  • Interpret test data, assembly tools, and have the ability to identify electrical and mechanical components utilized in area of assignment. Manipulative skills, including finger dexterity, arm-hand steadiness and adept hand-eye coordination (see details at close range)
  • Ability to work under minimum supervision with good time management skills
  • Must be a self-starter

Preferred Experience:

  • High School Diploma
  • Familiar and comfortable using computers and application software. Ability to navigate through several computer applications to run programs or enter data
  • 3 years experience as an assembler in an electronics manufacturing environment
  • General knowledge of manufacturing environment: raw materials, production processes, quality control, and other techniques for maximizing the manufacture of products
  • Experience in the medical ultrasound field is preferred but not required


QS Regulatory Compliance Specialist 

Position Summary:

This position will be responsible for supporting policies, procedures and processes related to FDA and ISO 13485 quality system elements; supporting EchoNous quality system to meet MDSAP and EU MDR requirements; administering internal audit and corrective action processes in conformance with national and international regulations; and oversight of employee training to key quality systems.

Primary Responsibilities:

  • Continuously improve, coordinate and manage company-wide quality system management efforts, to ensure compliance with regulatory authorities and industry best practices
  • Collaborate with peers to create, review, approve, improve, and manage company-wide SOPs, policies, and tools for quality management and regulatory compliance
  • Coordinate activities with external certification bodies and support all quality system activities to achieve and maintain ISO 13485, MDSAP and MDR certifications
  • Support RA/QA team in improvements to existing QMS and transitions to meet new domestic and international QMS/cGMP requirements
  • Prepare annual internal audit plans and oversee audits as principal lead auditor
  • Assign and support auditees to address findings and plan corrective actions
  • Manage issues and guide cross-functional teams in ensuring accurate root cause analysis, corrective/preventive action implementation, confirmation of effectiveness and communication to interested parties
  • Support and guide service team with complaint investigations and assessment of reportable complaints and field corrective actions
  • Manage monthly cross-functional team meeting to review supply chain, production, post-market and QMS metrics
  • Oversee cross-functional matrix of quality system training assignments and support quality system training and presentation materials
  • Support RA/QA management in preparation and execution of management review meetings by summarizing internal audits, complaints, CAPAs and opportunities for improvement
  • Support and guide supply chain team in performing supplier qualifications, audits and corrective actions
  • Support administration of the electronic document management system

Qualifications/Skills/Experience:

Depending on experience, the Specialist or Associate-level candidate will have a working knowledge of medical device quality management system regulations and guidance.  The individual should have some experience in best QMS practices with a view to end-user satisfaction and international regulatory expectations.  

  • Minimum 2-4 years of compliance-focused education and/or experience working within medical device manufacturing quality management systems
  • Strong familiarity with 21 CFR Part 820, ISO 13485, MDD/MDR, and MDSAP 
  • Lead auditor certification to ISO 13485:2016 is preferred
  • Experience in quality assurance processes (root cause, risk assessment, CAPA)
  • Reliable self-motivation, leadership and training skills
  • Strong communication skills – both written and oral


Document Control and Configuration Analyst

Position Summary:

This position will be responsible for sustaining EchoNous electronic change control and records system; managing all documentation control activities throughout the full product quality lifecycle in accordance with EchoNous quality management system and federal and international regulations; and maintaining system configurations to support design and ensure successful product deployment. This position will also be responsible for supporting labeling and UDI activities as well as ensuring company-wide training is up-to-date.

Primary Responsibilities:

  • System owner of EchoNous document and change control system
  • Review documentation for completeness, accuracy and compliance with established policies, procedures, and naming conventions
  • Collect and maintain manufacturing documents and records of the latest revision level and ensures that obsolete documentation is removed from distribution / publication
  • Manage off-site archival of paper documents
  • Manage the change control process including review and approval of product structure and information for accuracy including ERP coding and supplier and/or manufacturer details
  • Ensure change description is clear and valid, with enough detail and rationale to effectively initiate and drive the change
  • Analyze the impact of changes to products and their associated documentation and components
  • Review changes to determine interchangeability and appropriate actions
  • Maintain document, record, and change control procedures
  • Manage PLM system training for all users
  • Develop and deliver training of QMS processes including document, record, and change control processes 
  • Manage and assign electronic training to team members per established training matrix
  • Provide cross-functional support and guidance for the development and maintenance of quality documentation, procedures, work instructions, templates, BOM configuration, and RoHS compliance
  • Create and modify product labels or other labeling materials to support regulatory compliance and cross-functional business requirements
  • Support internal and external audits and inspections
  • Perform routine and ad hoc document control metric reporting and analysis

Qualifications/Skills/Experience:

  • Technical degree with 2-3 years’ experience in documentation and/or change control
  • Experience in regulated manufacturing environment (e.g., medical device, aerospace, automotive, etc.) is preferred
  • Background in Quality, Regulatory, Engineering, or IT-related field is preferred
  • Experience with ERP, PLM, and MES systems and/or manufacturing documentation (e.g., BOMs, item masters, etc.)
  • Experience reviewing engineering changes (e.g., drawings, procedures, product structure, etc.) with an aptitude for detail
  • Proficiency with computers, including Microsoft Office Suite (Word, Excel, PowerPoint) and material / document control software
  • Excellent analytical, verbal communication, and writing skills
  • Ability to work in a team environment as well as independently and with minimal supervision
  • Possess the ability to negotiate with, or persuade / influence others
  • Ability to detect potential problems and recommend corrective actions
  • Strong focus on customer service
  • Exhibits high degree of initiative and good judgment
  • Strong attention to detail and accuracy
  • Strong time management, organizational, and prioritization skills
  • Ability to effectively manage multiple projects and priorities
  • Ability to interface professionally at all levels of the organization

Interested in joining the team?

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