Applies a solid understanding of medical device/combination product development toward the development of new products and remediation of Design History Files and testing programs. Creates client specific deliverables to support development or lifecycle management activities.
Essential Duties and Responsibilities: (The incumbent will perform other duties as assigned.)
Supports organization through authoring of protocols and reports necessary for execution of test method validations, design verification testing, aging testing, etc. for clients.
Works closely with engineers and project management to author documents based on defined priorities and committed timelines.
Perform testing within laboratory, as needed. May oversee test execution performed by test operators.
Maintains a culture of continuous improvement while accelerating delivery of commitments.
Supports creation of new product development and lifecycle management deliverables for medical devices and/or combination products, including plans, product requirements and risk documentation, on time and within project budget.
May independently plan, schedule and lead small testing projects within a broader project.
Identifies areas of project risk, escalates issues and risks in an expedient manner, and actively proposes solutions.
Assures work activities are conducted in a manner compliant with all applicable regulations and industry standards.
Assures laboratory activities are conducted in compliance with all applicable EdgeOne or client training and GLP requirements.
Bachelor’s degree in Engineering (BME or ME).
3-5 years of experience in medical device development and designing/executing design verification and test method validations.
Experience leading the development and execution of testing protocols and reports Familiarity with ISO 14971:2007, 13485:2016, and 21CFR820 required.
Strong multi-tasking, time management, technical writing, and communication skills are required.
Highly motivated self-starter who can work with minimal supervision or as part of team.
Working knowledge of MiniTab and Microsoft Project is strongly preferred.
Familiarity with ISO 11040-4, 11040-8 and 11608-1, -2 and -3 preferred.
Working knowledge of experimental design statistical analysis is preferred.