Project Engineer

Essential Duties and Responsibilities

• Managing and executing all design control activities
• Managing vendor interaction for projects
• Maintaining project documentation
• Serving as team liaison with other Company functions
• Hands-on involvement with all phases of medical device development
• Conceptualization and 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.
• Participating in and/or leading project management activities such as regular planning events, partner communications, and resource coordination
• Developing and leveraging 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 publishing associate reports
• Conducting basic market and intellectual property research
• Maintaining Design History Files in accordance with established procedures
• Participating in and leading design review and design transfer activities
• Transitioning new products into production
• Participating, as needed, in efforts associated with continuous improvement, regulatory compliance, and other organizational capability initiatives
• Building and maintaining 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
• Excellent communication skills to maintain a professional attitude with all internal and external customers
• Good organizational skills
• Good understanding of accounting in a manufacturing environment

Education and 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