R&D Engineer

SCIENTIA VASCULAR INC•West Valley City, UT

About The Position

Responsible for the development and implementation of new or updated test methods for assessing the performance and design of medical devices. The Test Engineer will support cross-functional development teams by identifying product testing needs, developing the required test, and implementing that test method per a test method validation plan. This position will work under general direction and have latitude in determining how to solve a variety of testing challenges and problems.

Requirements

BS in Engineering
Minimum of 5 years engineering experience.
Test Method development experience
Familiar with TMV methodologies (Gage R&Rs) and use of Minitab or statistical software to analyze TMV data.
Hands-on ability to troubleshoot equipment
Experience in test fixture design and fabrication (i.e. Machine shop experience, CNC Mill, 3D printing, Lathe, etc.)
Strong written and oral communication skills.
Proficient with Microsoft Excel and Word.

Nice To Haves

Medical device background preferred but not required; experience with test methods from other manufacturers acceptable if work has mechanically based.
Experience with medical device design controls preferred
3D modeling (SolidWorks)
Experience with test equipment software (I.E. Bluehill on Instron) preferred

Responsibilities

Responsible for test method development for improvements to current tests or implementing new test methods.
Identifying necessary cross functional team members (R&D, Quality, Operations, Regulatory, etc.) and leading this group to develop a test method implementation plan (i.e. TMV protocol/report, Gage R&Rs).
Participates in and successfully contributes to product development project teams with regards to test method needs and development to maintain project timelines.
Works independently to plan and schedule own activities necessary to meet timelines.
Work with R&D Technician team to coordinate test method feasibility testing and test method development activities.
Independently designs & sources test fixturing or works with Automation/Equipment team to develop more complex test fixtures as needed.
Work with testing equipment suppliers to source testing equipment and manage the implementation.
Manage all installation and qualification requirements for test fixtures or equipment related to test method development activities.
Draft and release Test Method documentation as needed along with applicable testing analysis files in Excel, Python, etc.
Draft and release TMV protocols/reports and supporting documentation as needed in Quality Document Control/ERP System
Performs troubleshooting/support on technical issues for ongoing testing (i.e. equipment is not working correctly, not recording data, etc.)
Comply with applicable FDA and international regulatory laws and standards
Maintains a comprehensive and accurate laboratory notebook, document concepts, designs, drawings, and processes.
May train and/or provide work directions to technicians or engineers.
Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing to ensure project success.
Other duties as assigned with or without accommodation.