Summary

Manufacturing Engineer is a staff level position with responsibility to work with high attention to detail on engineering assignments related to PTS analyzers and manufacturing equipment and processes to produce medical diagnostics devices. This position will be responsible for determining design feasibility, sustainability, and supporting cross-functional departments for order execution. The Manufacturing Engineer will take the lead in electro-mechanical prototype development, equipment repairs and upgrades, design verification, root cause analysis, support of 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.

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 issue resolutions
• Write product specifications, document test results, prepare product operating instructions, and review technical literature
• Participate in Factory Acceptance / Site Acceptance testing activities

Qualifications

• Background in medical diagnostics or devices preferred
• Experience with equipment/process validation
• Experience using risk mitigation tools such as PFMEA and Control Plans
• Strong mechanical aptitude; hands-on capability for troubleshooting and repairs
• Working with analytical software will be required
• Detailed, meticulous application of engineering principles
• Able to provide leadership or mentorship among team members; provides support and encourages collaboration
• Experience with automated assembly lines preferred
• Willingness to travel to supplier / PTS sites as needed

Education and/or Experience

• Bachelor's degree (B.S.) in Mechanical Engineering or related Engineering discipline
• Minimum of five (5) years hands-on related experience in a design, development, and manufacturing environment
• Working knowledge of the medical diagnostics / medical device industry

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Employee works in a typical office and manufacturing environment.

Quality Commitment

This position requires compliance with applicable quality system and regulatory requirements. This individual adopts a "quality in everything we do" approach to all aspects of the execution of responsibilities of this position. Through vigilance, this individual remains alert to any potential compliance situations and must report such observations to managers and the Head of Quality.

Statement of Other Duties Disclaimer

This job description in no way states or implies that these are the only duties to be performed by this employee. This employee will be required to follow any other instructions and to perform any other duties requested by their supervisor.