This project focused on the development, documentation, and validation of electrical test systems used for design verification of medical devices.
Will oversee and support new test system builds, working closely with technicians to debug systems and document build instructions, system requirements, and bill of materials.
Role will also support validation of test systems and test methods, including hardware and software debugging as needed.
Develop and maintain test system documentation including build instructions, system requirements, and bill of materials.
Support validation of test systems and associated system software.
Develop, update, and validate test methods and calibration procedures in compliance with work instructions and SOPs.
Procure equipment and coordinate shipment of test systems and supporting equipment to multiple geographies.
Provide input to project goals, schedules, and progress, and recommend revisions as appropriate.
Communicate technical progress, risks, and trade-offs of deliverables to project leadership and recommend mitigation actions as needed.
Lead and coordinate project activities with engineers and technicians during the design support, assembly, debug, and validation of test equipment.
Support specification, assembly, and debug of automated test equipment and processes required for design verification testing.
Demonstrate technology development and product development system knowledge through delivery of high-quality, compliant engineering deliverables.
Education/Experience:
Bachelor’s degree or higher in Electrical Engineering or a related field.
9+ years of engineering or related experience with a bachelor’s degree, or 7+ years with a master’s degree.
Strong electrical and/or systems engineering problem-solving skills and attention to detail.
Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources.
Preferred:
Familiarity with FDA Quality System Regulations (21 CFR 820) and ISO 13485.
Experience with statistical techniques such as Gage R&R and t-tests, including use of Minitab.
Experience with medical device design verification and test method validation.
Experience with LabVIEW software development for automated test systems.
Familiarity with electrical schematics, wiring diagrams, and PCB layout.
Experience with document control and documentation systems.
Ability to build strong working relationships across the organization and with external stakeholders
