Manufacturing Engineer

SummaryManufacturing 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 ResponsibilitiesInteract well with Manufacturing, Engineering, Quality, and R&D personnelDaily interfacing with manufacturing staff to ensure manufacturing lines are up and running efficientlyExhibit quality of work and documentation habits exceeding the needs of those employed in the medical diagnostics industryGenerate formal reports and presentations to support Quality System and business needsPerform product and process verification and validation activities in a regulated industryWork effectively with outside vendors of materials and equipmentSupervise and perform maintenance to production equipmentMonitor and analyze mechanical devices for problemsPerform root cause analysis and work towards resolutionsDesign of experiments approach for assessing mechanical and product-based performanceDevelop and test devices for improvementRecommend design changes, cost reductions, warranty improvements, and manufacturing issue resolutionsWrite product specifications, document test results, prepare product operating instructions, and review technical literatureParticipate in Factory Acceptance / Site Acceptance testing activitiesQualificationsBackground in medical diagnostics or devices preferredExperience with equipment/process validationExperience using risk mitigation tools such as PFMEA and Control PlansStrong mechanical aptitude; hands-on capability for troubleshooting and repairsWorking with analytical software will be requiredDetailed, meticulous application of engineering principlesAble to provide leadership or mentorship among team members; provides support and encourages collaborationExperience with automated assembly lines preferredWillingness to travel to supplier / PTS sites as neededEducation and/or ExperienceBachelor's degree (B.S.) in Mechanical Engineering or related Engineering disciplineMinimum of five (5) years hands-on related experience in a design, development, and manufacturing environmentWorking knowledge of the medical diagnostics / medical device industryWork EnvironmentThe 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.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 CommitmentThis 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 DisclaimerThis 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.