Sr. Product Development Engineer (Instrument) Ekos
THIS JOB HAS EXPIRED SUPERVISOR: VP, Systems Integration
MAIN PURPOSE OF JOB
To conceive, design and develop medical device instrumentation through analysis of user
requirements, system specification, engineering design, prototyping, risk assessment and appropriate
MAIN JOB DUTIES/RESPONSIBILITIES
? Design, develop and prototype new medical device instrumentation in accordance with the
company Product Development Process (PDP) requirements.
? Evaluate the user requirements for the next generation of instrumentation.
? Evaluate the feasibility of various concepts to meet the functional, clinical and customer
requirements using engineering analysis and testing.
? Develop timelines and cost estimates for development tasks and appraise management of
performance against plan.
? Generate design history documents in compliance with GMP, QSR, ISO, and the company PDP
? Identify and manage outside vendors to provide design and testing services as needed.
? Obtain components/supplies/equipment to support prototype assembly, and conduct preliminary
OEM vendor assessment/selection.
? Provide input into the creation/modification of Product Specifications in alignment with
? Evaluate, document, and implement potential design and process changes to improve product
performance, manufacturability, safety or cost consistent with GMP or company PDP process.
? Assess reliability, safety, performance and risk of new designs & methodologies. Coordinate and
communicate development schedules and compatibility or design issues throughout the team
? Oversee testing and theoretical analysis of products to determine product safety and efficacy.
? Identify, develop and implement pre-production assembly methods and equipment; Coordinate
with OEM vendor activities relative to communication of specifications, development schedules,
and system compatibility.
? Transfer designs to manufacturing through a liaison with manufacturing engineering and external
? Bachelor?s degree in Engineering and more than ten years of relevant engineering experience
(electronic design) in medical device development or other regulated electronics industry.
? Experience in the testing and qualification of medical electrical systems is required.
? Working knowledge of electronic development tools is required.
? Good written and oral team communication skills are required.
? Strong mathematical analysis and test design skills are required.
? Ability to travel is required.
Sr Product Development Engineer -- Instrument ? Instrument Rev A ? 10.9.12 Sr Product Development Engineer -- Instrument ? Instrument Rev A ? 10.9.12
? Basic knowledge of human anatomy and physiology and clinical applications is desirable.
? Working knowledge of SolidWorks is desirable.
? GMP, ISO 13485, and QSR knowledge as practiced in the medical device industry is desirable.
? Selection of design direction, with the involvement of team members and with design reviews.
? Timeline and specification planning, with the involvement of team members and with design
? Documentation of engineering testing and results with conclusions in reviewed reports.
? Creation of documentation change orders.
? Preliminary selection of suppliers and ability to develop relationships with those suppliers.
? Selection and purchasing of equipment, materials and supplies with one-over review.
? Origination of testing/test requirements definition.
||11911 North Creek Parkway South |
Bothell, WA 98011
THIS JOB HAS EXPIRED