Perform standard Mechanical Engineering tasks within a sustaining engineering role function, specifically in a manufacturing environment.
Select appropriate techniques to solve problems and make design recommendations under direction of supervisor.
Assess results for application, validity and conformance to specifications.
Utilize engineering tools to solve technical problems e.g., CAD design, FMEA, Finite Element Analysis, Process Modeling, Design of Experiments.
Display a solid technical understanding of engineering principles and procedures (e.g. CAD and its application or scheduling a series of technical tasks utilizing software-based tools).
Requires working in a team environment with cross-functional team members, such as manufacturing, quality, regulatory, and other R&D departments.
Requirements
Bachelors degree in Mechanical Engineering with 3-5 years of relevant experience in mechanical design.
Experience in hardware and plastic component design using Pro-Engineer and/or SolidWorks software.
Familiar with appropriate FDA QSR and ISO regulations: design controls, document controls, design verification and validation, hazard analysis techniques, regulatory approval methods, and overall medical device industry knowledge.
Must possess a firm foundation in the basic principles of their respective engineering discipline.
Able to manage projects, coordinate contractors, and direct the activities of a technician.
Strong critical thinking skills and the ability to function in a sometimes-ambiguous situations.
Excellent verbal and written communication skills.