Are you an engineer who thrives on solving complex problems in the medical device industry? Do you often find you are most successful in a work environment that challenges your strong intellectual curiosity? We have an exciting opportunity for a Sr Electrical Engineer – Medical Devices who is looking to exercise their problem-solving and intellectual curiosity at our Technical Research and Training Center of our medical device division, Diversatek Healthcare, in the greater Denver, CO area. This person will participate in the development of products throughout the entire cycle, from inception to technical design, and through commercialization. This candidate will have solid collaboration and problem-solving skills, and an understanding of the key drivers in the medical device industry.
Responsibilities
• Support the design and development of hardware and firmware for our next-generation Mucosal Integrity system controller.
• Provide Engineering Production support for the current line of High-Resolution Manometry, Reflux, and Mucosal Integrity products. Must be able to troubleshoot complex production-related issues and work to improve processes and testing.
•Lead product verification effort as required to qualify and release medical diagnostic devices.
•Lead the transition from Engineering Development to Production by supporting the design, documentation, test procedures, and fixturing.
•Support automated production test hardware and software.
•Interact with other departments and teams within the company, taking an active role in gathering pertinent information to ensure continuity of design.
•Perform investigations on failure analysis and recommend corrective actions.
•Ensure product development activities comply with FDA, CE, and ISO standards.
•Develop and maintain control documentation, including drawings, specifications, and procedures.
•Other tasks as assigned.
Technical Qualifications
•A B.S. in Electrical Engineering with at least 10-15 years of industry experience as an Electrical Engineer.
•Knowledge and experience with design and firmware development of microcontroller-based systems.
•Proficient in Microsoft Word and Excel
•Experience in the Medical Industry with FDA, CE Mark, and ISO standards is desired
•Good technical writing skills
•Strong verbal and written communication skills
•Must possess strong problem-solving, decision-making, analytical, and organizational skills.
•Must be willing to work in a team environment, interacting with all levels of the organization
Physical Qualifications
• Prolonged periods of sitting at a desk and working on a computer.
