Process / Product Mechanical Engineer is a staff level position with responsibility to work with high attention to detail on engineering assignments related to CO analyzers and manufacturing equipment for the production of medical diagnostics devices. This position will be responsible for determining design feasibility, sustainability, preparing SolidWorks drawing, supporting cross functional departments for order execution. The Process / Product Mechanical Engineer will take the lead in electro-mechanical prototype development, equipment repairs and upgrades, design verification, root cause analysis, support of Sustaining Engineering projects, troubleshooting of manufacturing equipment issues and testing for compliance with medical device design standards. Projects involve the construction, characterization, and troubleshooting of mechanical systems containing electronic, optical, and software controls used in new products, prototypes, test fixtures and manufacturing equipment. Work includes mechanical design, knowledge of digital and analog electronics, optics, and mechanical manufacturing systems. This position generates formal reports and presentations using applicable software. This position is also responsible for ensuring compliance with regulatory requirements of the Quality System documentation as required for design control. The Process / Product Mechanical Engineer will help direct the efforts of the mechanics and manufacturing engineers as well.
ESSENTIAL DUTIES AND RESPONSIBILITIES
· Interact well with Manufacturing, Engineering, Quality and R&D personnel
· Daily interfacing with manufacturing staff to ensure manufacturing lines are up and running efficiently
· Exhibit quality of work and documentation habits exceeding the needs of those employed in the medical diagnostics industry.
· Generate formal reports and presentations to support Quality System and business needs
· Perform product and process verification and validation activities in a regulated industry
· Work effectively with outside vendors of materials and equipment
· Supervise and Perform maintenance to production equipment
· Monitor and analyze mechanical devices for problems
· Perform root cause analysis and work towards resolutions
· Design of experiments approach for assessing mechanical and product-based performance
· Develop and test devices for improvement
· Recommend design changes, cost reductions, warranty improvements, and manufacturing issues
· Write product specifications, document test results, prepare product operating instructions and review technical literature
· Participate in test runs or field installations
· Background in medical diagnostics or devices preferred
· Strong mechanical aptitude / hands on for troubleshooting and repairs
· Working with analytical software will be required.
· Detailed, meticulous application of engineering principals
· Highly proficient with SolidWorks
· Proficient with manufacturing PLC software
· Able to provide leadership or mentorship among team members; provide support and encourages collaboration
EDUCATION and/or EXPERIENCE
· Bachelor's degree (B.S.) in Mechanical Engineering or related Engineering Technology.
· Minimum of five (5) years hands-on related experience in design, development and manufacturing environment.
· Working knowledge in the medical diagnostics / medical device industry