Title: Senior Engineer, ManufacturingLocation: OnsiteStatus Type: Full TimeQualificationsBachelor's Degree in Mechanical, Industrial, Biomedical, or related Engineering from an accredited university; or education/experience equivalentA minimum of 6 years of manufacturing engineering (equipment/process design and support) in a regulated industry such as Medical Device, Pharmaceutical, or Food; OR a master's degree in related field plus 4 years' experiencePreferredExperience with medical device manufacturing (heat staking, ultrasonic welding, press assembly, adhesives, leak testing) and inspection technologies (vision systems, pressure decay, flow testing)Experience programming vision systems, robotics, and PLCExperience designing and implementing high-volume manufacturing equipment preferred, i.e., production 1M+ annual, cycle timeSix Sigma Yellow/Green Belt CertificationSkills & CompetenciesAbility to effectively create 3D engineering models, assemblies, fixtures, and drawings (Solidworks preferred)Ability to create experimental designs and collect, interpret, and analyze data using statistical techniques (Minitab preferred)Strong technical writing skills (planning, protocol writing, execution, report writing, Operating Procedures)Knowledge of PLC and HMI programming for equipment troubleshooting or minor modifications (Allen Bradley preferred)Strong understanding and application of 21 CFR 820 Medical Device Quality System Regulation, especially 21 CFR 820.70 for equipment qualification and 21 CFR 820.75 for process validation (FAT, SAT, IOQ, OQ, PQ, PPQ)Must be able to work effectively on electrical, mechanical, and/or software related issues associated with equipmentStrong analytical and creative problem-solving skills, able to provide solutions to complex technical challengesProficiency utilizing the MS Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook)Communicate effectively through both verbal presentation and technical writing to various internal stakeholders of varying technical abilitiesDemonstrated ability to prioritize tasks and lead a varied workload to meet team objectives. Assign priority and schedule tasks to provide timely solutions to achieve resultsResolve internal and external (customer or supplier) issues related to manufacturability and performance of productMaintain and repair equipmentDelegate tasks to technicians and co-ops within the departmentParticipate in cross functional teams and ideation sessionsWork with functional managers and partners to ensure project goals are metProvide technical guidance and coaching of other engineersContributes to project planning and execution to meet schedule and budget requirementsAuthor Quality System documentation to support all of the responsibilities above, including but not limited to change control, engineering change orders, equipment forms, calibration forms, and preventive maintenance formsNearest Major Market: Cincinnati#J-18808-Ljbffr.