Manufacturing Engineer

ECHONOUS INC•Redmond, WA

10d•$92,000 - $112,000•Onsite

About The Position

We are seeking a hands-on Manufacturing Engineer to own the assembly, test, and continuous improvement of the ultrasound probe cell. This onsite role serves as the technical authority on the probe production floor, bridging R&D—including mechanical, electrical, and software engineering—and factory operations. The engineer defines, documents, and optimizes processes for complex electromechanical medical devices across sustaining production and new product introduction (NPI). The role includes direct collaboration with assembly technicians and operators, troubleshooting production issues, building and reworking engineering and test assemblies, and improving processes, fixtures, tooling, test equipment, and production systems. It also supports validation, data-driven improvement, manufacturing documentation, design-for-manufacturability activities, engineering changes, and quality and regulatory compliance.

Requirements

A bachelor's degree in Mechanical, Electrical, Manufacturing, or Biomedical Engineering, or a related discipline, plus at least 3 years of manufacturing, test, or process engineering experience; or at least 5 years of hands-on manufacturing, test, or process engineering experience in a high-reliability hardware environment.
Demonstrated success solving complex production problems with structured root-cause analysis methods and verifying corrective actions.
Strong hands-on electrical troubleshooting skills, including reading schematics and using a multimeter and oscilloscope.
Proficiency in fine-pitch soldering and rework of PCBAs, wire harnesses, and cables.
Working knowledge of electrical systems such as PCBAs, harnesses, sensors, and power distribution, as well as mechanical assemblies, precision tolerances, enclosure fit, and structural hardware.
Experience applying Lean Manufacturing methods, including 5S, Kaizen, Value Stream Mapping, and Kanban, as well as pFMEA, DOE, and SPC.
Advanced Excel skills and comfort with statistical software for analyzing yield and defect data.
Excellent written and verbal communication, including the ability to write clear, unambiguous visual work instructions.
Strong interpersonal skills and emotional intelligence 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.

Nice To Haves

Experience in an ISO 13485 or FDA-regulated medical device environment; experience with other regulated or high-reliability electromechanical products will also be considered.
Ability to write or modify Python scripts for test automation, data collection, or analysis.
Familiarity with Ubuntu or other Linux environments, including command-line use on production test stations.
Proficiency with SolidWorks, Creo, or similar 3D CAD software for fixture and jig design and visual assembly illustrations.
Experience with transducer or probe assembly, acoustic shielding, coaxial cabling, high-frequency signal integrity, or acoustic output testing.
Familiarity with Android or iOS devices and applications used in production or testing.
Experience managing change orders and BOMs in a Product Lifecycle Management system.
IPC J-STD-001 or IPC-A-610 certification.

Responsibilities

Own probe assembly and test processes for sustaining production and NPI builds.
Work alongside assembly technicians and operators to resolve technical issues, train staff on new processes, and streamline workflows.
Design, implement, and improve assembly procedures, fixtures, tooling, test equipment, and cell layout to improve yield, quality, and throughput.
Build and rework engineering and test assemblies for NPI, validation, and design engineering activities.
Lead structured root-cause investigations into production failures and drive verified corrective actions.
Diagnose electromechanical failures at component, subassembly, and system levels using schematics and test equipment.
Analyze production rejects and customer returns, including teardown and cable dissection, to isolate failure locations in support of Service and Engineering.
Support and troubleshoot production test systems, including acoustic output testing and reference data collection in line with applicable standards.
Partner with software and electrical engineering to improve production software tools and test automation, and transfer new tools into production.
Support equipment, process, and test method validation (IQ/OQ/PQ) and verification activities.
Analyze yield, defect, and NCR trend data to prioritize improvement efforts.
Apply DOE and SPC to characterize, control, and improve processes.
Identify, justify through ROI, and implement fabrication or test methods and equipment that improve capability and reduce unit cost.
Author, edit, and maintain visual assembly instructions, test and rework instructions, and Manufacturing Process Specifications for mechanical housings, cabling, acoustic transducers, and PCB integration.
Participate in NPI design reviews and advocate for Design for Manufacturability, Assembly, and Testability with design engineers and suppliers.
Prepare and manage Engineering Change Orders, BOMs, and deviations in PLM to transfer designs and process changes into production.
Maintain compliance with FDA QMSR (21 CFR Part 820), ISO 13485, and internal quality standards; support NCRs and CAPA.