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.
• Bachelors 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. Masters Degree a plus.
• Electromechanical experience a plus.

Required Experience:

IC