Manufacturing Engineer

EchoNous, Inc; Redmond (WA); On-site; USD 92,000 - 112,000; Full time

Job summary

EchoNous, Inc in Redmond, WA seeks a hands-on Manufacturing Engineer to own the assembly, test, and continuous improvement of ultrasound probe cell on-site. You will bridge R&D and factory operations, defining and optimizing processes for complex electromechanical devices across sustaining production and NPI.

Strong RCA and soldering skills required. The role focuses on improving yield, quality, and throughput, supervising technicians, and validating test systems within FDA/ISO-aligned quality

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Manufacturing, or Biomedical Engineering (or related) plus 3+ years manufacturing/test/process eng experience; or 5+ years hands-on experience in high-reliability hardware.

Responsibilities

• Own probe assembly and test processes for sustaining production and NPI.
• Work with assembly technicians to resolve issues and train on new processes.
• Design and improve fixtures, tooling, and test equipment to boost yield and throughput.
• Lead root cause investigations on production failures and implement corrective actions.
• Support production test systems and data collection for validation and QA.
• Participate in NPI design reviews for manufacturability and testability.

Skills

Root Cause Analysis

Electrical Debug

Soldering

Electromechanical Fundamentals

Lean & Quality Tools

Data Analysis

Education

Bachelor’s degree in Mechanical, Electrical, Manufacturing, or Biomedical Engineering

Tools

Python Scripting

Linux / Ubuntu

3D CAD

Ultrasound Knowledge

Mobile Platforms

PLM Systems

IPC J-STD-001 / IPC-A-610

Job description

Manufacturing Engineer# Manufacturing EngineerHot JobRedmond, WA 98052## OverviewSalary Range$92,000.00 - $112,000.00 Salary/yearLevelExperiencedPosition TypeFull TimeJob ShiftDayEducation Level4 Year DegreeTravel PercentageNoneCategoryEngineering## Description## About the RoleWe are seeking a hands-on Manufacturing Engineer to own the assembly, test, and continuous improvement of our ultrasound probe cell. In this on-site role, you will be the technical authority on the probe production floor, bridging R&D (mechanical, electrical, and software engineering) and factory operations.You will define, document, and optimize processes for complex electromechanical medical devices across both sustaining production and new product introduction (NPI). If you are a strong root-cause problem solver who is comfortable with a soldering iron, an oscilloscope, and a technician's questions on the line, we want to hear from you.## Key Responsibilities### Process Engineering & Floor Support* Probe Cell Ownership: Own probe assembly and test processes for both sustaining production and NPI builds.* Assembly Line Engagement: Work directly alongside assembly technicians and operators to resolve daily technical issues, train on new processes, and streamline workflows.* Process Optimization: Design, implement, and continuously improve assembly procedures, fixtures, tooling, test equipment, and cell layout to maximize yield, quality, and throughput.* Special Builds: Build and rework engineering and test assemblies to support NPI, validation, and design engineering activities.### Troubleshooting & Failure Analysis* Root Cause Analysis: Lead structured root cause investigations (e.g., 5 Whys, Fishbone, 8D, fault tree) on production failures and drive effective, verified corrective actions.* Electrical Debug: Diagnose complex electromechanical failures at the component, sub-assembly, and system levels using schematics, multimeters, oscilloscopes, and other test equipment.* Failure Analysis: Perform failure analysis on production rejects and customer returns, including teardown and cable dissection to isolate failure locations, in support of Service and Engineering.### Test & Production Systems* Production Test: Support and troubleshoot production test systems, including acoustic output testing and reference data collection, in line with applicable standards.* Production Software & Tools: Partner with software and electrical engineering to improve production software tools, test automation, and the transfer of new tools into production.* Validation: Support equipment, process, and test method validation (IQ/OQ/PQ) and verification activities.### Continuous Improvement* Data-Driven Focus: Analyze yield, defect, and NCR trend data to prioritize improvement efforts.* Statistical Methods: Apply DOE and SPC to characterize, control, and improve processes.* Cost & Capability: Identify, justify (ROI), and implement new fabrication or test methods and equipment that improve capability and reduce unit cost.### Documentation & Compliance* Work Instructions: Author, edit, and maintain clear, visual Assembly Instructions (AIs), test and rework instructions, and Manufacturing Process Specifications (MPS) for mechanical housings, cabling, acoustic transducers, and PCB integration.* DFM / DFT: Participate in NPI design reviews, advocating for Design for Manufacturability, Assembly, and Testability with design engineers and suppliers.* Change Management: Prepare and manage Engineering Change Orders (ECOs), BOMs, and deviations in PLM to transfer designs and process changes into production.* Quality & Regulatory: Maintain compliance with FDA QMSR (21 CFR Part 820), ISO 13485, and internal quality standards. Support NCRs and Corrective/Preventive Actions (CAPA).## Qualifications## Qualifications & Skill Requirements### Education & Experience (one of the following)* Bachelor's degree in Mechanical, Electrical, Manufacturing, or Biomedical Engineering (or a related discipline) plus 3+ years of manufacturing, test, or process engineering experience; or* 5+ years of hands-on manufacturing, test, or process engineering experience in a high-reliability hardware environment.### Required Skills* Root Cause Analysis: Demonstrated track record of solving complex production problems with structured RCA methods and verifying the fix.* Electrical Debug & Soldering: Strong hands-on electrical troubleshooting skills, including reading schematics and using a multimeter and oscilloscope; proficient in fine-pitch soldering and rework of PCBAs, wire harnesses, and cables.* Electromechanical Fundamentals: Working knowledge of electrical systems (PCBAs, harnesses, sensors, power distribution) and mechanical assemblies (precision tolerances, enclosure fit, structural hardware).* Lean & Quality Tools: Experience applying Lean Manufacturing (5S, Kaizen, Value Stream Mapping, Kanban), pFMEA, DOE, and SPC.* Data Analysis: Advanced Excel skills and comfort with statistical software for analyzing yield and defect data.* Regulated Environment: Experience in an ISO 13485 / FDA-regulated medical device environment is highly preferred; experience with other regulated or high-reliability electromechanical products will be considered.### Preferred Skills (a Plus)* Python Scripting: Ability to write or modify Python scripts for test automation, data collection, or analysis.* Linux / Ubuntu: Familiarity with Ubuntu or other Linux environments, including the command line, as used on production test stations.* 3D CAD: Proficiency in SolidWorks, Creo, or similar for designing fixtures and jigs and creating visual assembly illustrations.* Ultrasound Knowledge: Experience with transducer/probe assembly, acoustic shielding, coaxial cabling, high-frequency signal integrity, or acoustic output testing.* Mobile Platforms: Familiarity with Android or iOS devices and applications used in production or test.* PLM Systems: Experience managing change orders and BOMs in a Product Lifecycle Management system.* Certifications: IPC J-STD-001 or IPC-A-610 certification.### Soft Skills & Working Style* Excellent written and verbal communication, with a proven ability to write crisp, unambiguous visual work instructions.* High emotional intelligence and the interpersonal skills to build trust with assembly technicians, quality engineers, and R&D designers.* Ability to prioritize and manage multiple assignments while maintaining a high level of quality.