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 ...