Project Engineer

ESSENTIAL DUTIES AND RESPONSIBILITIES

• 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.