Responsible for managing and executing all design control activities. Manage vendor interaction for projects. Maintain project documentation. Team liaison with other Company functions. Strong, hands-on involvement with all phases of medical device development. Conceptualization and primarily mechanical design of medical device procedures, instruments, and devices using fundamental engineering knowledge and principles. Solid modeling via SolidWorks of design concepts and creation of design drawings using ASME Y14.5, ISO, and GD&T principles. Creation of development documentation consistent with FDA CFR 820.30, such as product specifications, risk analyses, verification/validation reports, etc. Participate in and/or lead project management activities such as regular planning events, partner communications, and resource coordination. Develop and leverage working knowledge of relevant manufacturing processes to apply Design for Manufacturability. Designing, executing, and analyzing experiments, verification tests, and validation tests using statistical techniques and publish associate reports. Conduct basic market and intellectual property research. Maintain Design History Files in accordance with established procedures. Participate and lead in design review and design transfer activities. Transition new products into production. Participate, as needed, in efforts associated with continuous improvement, regulatory compliance, and other organizational capability initiatives. Build and maintain effective communication and relationships with internal and external customers regarding status, timing and design issues impacting the project. Background in Electromechanical with automated systems experience.
QUALIFICATIONS
Experienced product developer and project manager. Professional, polished demeanor, capable of leading discussions and ideation sessions with customers and internal staff members, comfortable interfacing with all levels of the organization. Demonstrated career progression through the product development ranks with an emphasis on translating customer requirements to practical designs. Candidate must possess excellent communication skills to maintain a professional attitude with all internal and external customers relating to this position. Good organizational skills. Good understanding of accounting in a manufacturing environment. EDUCATION and/or
EXPERIENCE
Experience using MS Office, Outlook, MS Project, or other Gantt Chart Software. Experience using accounting and ERP software. Experience using CAD software, SolidWorks a plus. Bachelor's degree from four-year college or university in a related engineering field; or one to two years related experience and/or training in a similar position; or equivalent combination of education and experience. Master's Degree a plus. Electromechanical experience a plus. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
