Senior Manufacturing Engineer Ekos
MAIN PURPOSE OF JOB
? Develop excellence in manufacturing through the application of engineering fundamentals,
applied research, and Design for Manufacturability (DFM) principles.
? Develop and implement manufacturing process and tooling improvements to increase
production yields and improve manufacturing throughput. Lead complex projects independently
with minimal supervision.
? Support R&D and sustaining engineering projects with Design for Manufacturability expertise,
development of production processes, documentation, and equipment and transfer to
MAIN JOB DUTIES/RESPONSIBILITIES
? Provide timely resolution of day-to-day production line problems.
? Establish assembly, test, and inspection procedures. Maintain and continuously improve
documents per change control procedures to assure accuracy and compliance.
? Research, develop, and implement improvements to manufacturing processes, procedures, and
equipment to improve product quality, increase throughput and reduce process variability.
? Document experiments, tests, and production development activities in lab notebook, technical
reports, or evaluation reports.
? Design, fabricate and evaluate manufacturing and inspection equipment. Perform Tool
Qualification, as needed. Establish documentation to support implementation of new
equipment in production.
? Specify, equip and maintain manufacturing facilities. Propose and support layout changes to
improve efficiency of production line(s), adjust to volume requirements, and integrate new
? Perform Design Verification, Process Validation, and Product/Process Performance Qualification
activities in compliance with Quality Management System.
? Interface with suppliers for problem resolution, process development, and procurement of
equipment. Develop outside OEM services, where appropriate.
? Review Operations metrics with management and prioritize projects to address quality issues
and meet throughput demands, i.e., reduce scrap and minimize risk of manufacturing errors.
? Participate in the development of next generation devices, provide input from a manufacturing
and quality perspective, plan/prepare the manufacturing area for pilot production activities and
transfer to manufacturing.
? Support R&D projects with DFM input and design review.
? Train production assemblers on new or modified equipment/processes. Provide guidance to
Manufacturing Engineering Technicians with repair and maintenance of production tooling. ? Support Operations with changes to production paperwork that facilitate training of a culturally
diverse workforce with English as a Second Language (ESL).
? BS in Engineering (ME, IE, ChemE, or EE) and 7+ years of successful experience in Manufacturing
Engineering in a medical device or precision electro-mechanical product environment
? SolidWorks capability
? Expertise in relevant materials fabrication equipment/techniques
? DFM, DOE expertise. Strong understanding of statistical analysis methods, Six Sigma and Lean
? Expertise in GMP, ISO 13485, MDD, and QSR requirements
? Expertise in team methods of product and process development
? Technical writing excellence
? Willingness to work in clean room, laboratory or office environments
? Ability to program ladder logic and standard machine/ process control software desirable
? Document engineering conclusions in reviewed reports
? Generate Document Change Orders (DCOs) and sign DCOs as designee
? Select and purchase equipment, materials and supplies with one-over-one review
? Determine manufacturing direction and develop specifications and project timelines with the
involvement of team members and with management design review
? Mentor junior Manufacturing Engineers and Manufacturing Engineering Technicians
? Travel up to 10% of time
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Bothell, WA 98011