R&D Engineer

Spectraforce Technologies

Jan 16, 2025
Job Title: R&D Engineer Location: Plymouth MN 55442 Duration: 12 months Shift Timing: 8am - 4:30pm Profile Overview: Leading an active lifestyle is important to the many people we serve. In Company's Electrophysiology (EP) division, we're advancing the treatment of vascular disease through breakthrough medical technologies, allowing people to restore their health and get on with their lives. As a R&D Engineer at our Plymouth, MN location, you will be part of our Electrophysiology (EP) Catheter team focused on providing R&D support a wide range of market-released diagnostic and imaging catheters. This role will involve a range of responsibilities including but not limited to failure analysis, design changes, requirement development, testing and data analysis, and test method development and validation. Job Responsibilities: Provides R&D support for market-released cardiac electrophysiology catheters Conducts feasibility studies to verify capability and functionality to support investigations and/or design changes Develops solutions to improve product function and manufacturability Directs support personnel and coordinates project activities Write and submit Engineering Change orders Maintains detailed documentation throughout all phases of a project Investigates and evaluates design changes, manufacturing changes, NCMRs, CAPAs and/or customer complaints Reviews or coordinates vendor activities to support development Research various cost-effective, alternative approaches to current designs and processes Involved in test method and fixture development Support development of risk management documentation (DFMEA, UFMEA, PFMEA, Fault Tree) Gain an understanding of the quality and regulatory requirements of Company, FDA and ISO regulations Required Qualifications: Bachelor's degree in mechanical engineering, Biomedical Engineering, Electrical or related Engineering degree 1-2+ years engineering experience required in regulated field Preferred Qualifications: 1-2+ years' experience in med device Exposure to a variety of manufacturing processes used in medical devices, specifically deflectable sheaths and/or EP Catheters preferred Familiarity with ultrasound, catheter ring-on-wire electrodes, magnetic location systems, and catheter manufacturing techniques Worked with an electronic document control system (Windchill, etc.) SolidWorks or other CAD experience Experience working within a team and as an individual contributor in a fast-paced, changing environment Strong verbal and written communications with ability to effectively communicate to all levels of the organization