Manufacturing Engineering, Assembly

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. 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.

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
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
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

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; Working with analytical software will be required
Detailed, meticulous application of engineering principles
Experience with automated assembly lines preferred
Willingness to travel to supplier / PTS sites as needed

Bachelor’s degree (B.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

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Employee works in a typical office and manufacturing environment.

Equal Opportunity Employer: PTS Diagnostics is an Equal Opportunity and E-Verify employer. Employment decisions for all applicants and employees will be made without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, age, national origin, marital status, veteran status, disability, or other characteristics protected under local, state, or federal law.

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.

Company Description PTS Diagnostics is an innovative point-of-care diagnostics solutions provider that partners with patients and healthcare professionals to provide the right information at the right time to make the right decisions. PTS Diagnostics is an innovative point-of-care diagnostics solutions provider that partners with patients and healthcare professionals to provide the right information at the right time to make the right decisions.