What are the responsibilities and job description for the Medical Device Test Engineer position at Beyondsoft Consulting?
Overview
Beyondsoft Consulting, Inc., is a leading technical solutions and consulting partner. We combine emerging technologies and proven methodologies to tailor elegant solutions that solve complex challenges and empower our customers to accelerate their business goals. Our services include end-to-end support for cloud, digital, data analytics, multi-language translation, and testing. Join the technical team of a top-of-the-line software, hardware, and R&D company.The Medical Device Test Engineer position offers a Monday through Friday work week with regular office hours, a comprehensive benefit package including holiday pay and paid time off, and is at an onsite, high-profile client location in beautiful Vancouver, Washington.
Responsibilities
• Creates and executes test protocols for qualifying medical equipment.• Tests created must be repeatable and accurate.• Test protocols must help qualify equipment to FDA/ISO 13485 requirements (IQ/OQ/PQ).• Observe equipment behavior and compare test results with predetermined parameters.• Collect and accurately gather good objective evidence using Good Documentation Practices• Maintain accurate logs, records, metrics, and follows procedures.• Participate in regular project meetings with client and project team.• Maintain professional, healthy working relationships with the client and other vendors.• Completes work with limited supervision and general instructions for new assignments.• Mentor and train new associate engineers and/or technicians.
Qualifications
• Minimum educational level preferred is a 4-year degree in Engineering or Science sectors. The educational requirement may be waived depending upon professional experience. • A minimum of five years' experience writing medical device testing protocols is preferred.• Knowledge of the concept and expectations of FDA/ISO 13485 tool qualifications is a must.• Professional and/or educational experience in a Bio Sciences lab with lab equipment is required.• Strong written, verbal, and interpersonal communication skills required with the ability to effectively communicate with varied levels of employees and clientele.• Ability to work independently and with a team.• Be physically able to sit or stand for extended periods, climb step stools, bend, kneel and stoop frequently.• Be willing to perform repetitive, sometimes sedentary work.• Software and/or hardware test engineer experience is a plus.• Strong attention to detail with ability to comply with changing priorities and requests.• At minimum, intermediate user knowledge and experience with PC's including Microsoft Office products like Word, Excel, and Access with comfortability navigating and viewing web pages.* This position requires candidates to be fully vaccinated for Covid-19 prior to starting.Beyondsoft provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type with regards to race, color, religion, age, sex, national origin, disability status, genetics, veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, and the full employee lifecycle up through and including termination.
