Senior Principal Engineer, Usability and Design Validation

Job Description

• Apply FDA human factors processes towards the development of medical devices and ensure it adheres to FDA guidelines and other regulatory bodies (IEC 62366, AAMI HE75, etc.).


• Represent Product Design Validation and Usability in cross functional project core-teams in the areas of Critical Care/Ventilation and associated consumable devices.


• Design, coordinate, and conduct Simulated Use Validation for medical devices, analyze and report on data, and present results and findings to multidisciplinary teams.


• Design, coordinate, and conduct formative and summative usability tests for medical devices, analyze and report on data, and present results and findings to multidisciplinary teams.


• Manage Product Design Validation testing cycles; provides consultation on complex projects and considered to be a high-level contributor or specialist


• Multi-task between different projects and programs to appropriately resource balance across multiple R&D and sustaining development and support activities


• Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles


• Possess a basic understanding of the Product Development Life Cycle and Usability Engineering process


• Demonstrate knowledge and application of standard testing methods; uses professional concepts and objectives to resolve complex issues in creative and effective ways


• As a Subject Matter Expert, influences and gains acceptance from others; able to convey complex information to other team members. Establishes collaborative relationships across the R&D Engineering function and the overall company


• Comply with applicable processes, regulations and standards for US and OUS regions


• Work independently with minimal guidance to determine methods and procedures on assignments; demonstrates expertise in a variety of Critical Care/Ventilation practices and procedures


• Goals and responsibilities generally communicated in "solution" or project-related terms; may supervise the activities of others

Qualifications

• 6+ years of related medical device experience


• Medical device product design validation experience


• Medical device product usability and human factors engineering experience


• Strong Written and Verbal Communication skills


• Proficient in Microsoft Word and Excel


• Bachelor of Science in Respiratory Care, Human Factors, Cognitive/Experimental Psychology, Industrial Design, Engineering Psychology or related field required


• Current License in Respiratory Therapy with RRT and RPFT designations preferred

About Aerotek:

Your success starts with the right career opportunity. Aerotek uses a people-focused approach to connect job seekers to incredible opportunities with leading organizations. Established in 1983, we've grown to become a consistent Best of Staffing® winner for talent satisfaction because of our dedication to exceptional service. Serving over 300,000 contract workers every year, we specialize in placing workers with engineering, scientific, professional and industrial skill sets. Aerotek is proud to offer competitive benefits, including contributory medical, dental and vision insurance, weekly pay, discounts on consumer goods and services and more.