Job Description Process Validation • Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities and develop Master validation plans for new processes or products. • Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities. • Work with the Process Development team to efficiently qualify new processes; assist on statistical sampling plans, and other development procedures. • Design and develop in-process and receiving quality systems for new processes and components • Generate equipment documentation, such as equipment entries, evaluations, PM and calibration procedures, as required. • Define gages, tools and equipment for the test methods developed. • Generate manufacturing instructions for new processes being developed • Work cross-functionally with other departments to accomplish PD tasks. Process Development • Be able to manage process development projects from conception to implementation, ensuring project deadlines and objectives are met. • Familiarity with a variety of technologies and equipment used in the industry to carry out manufacturing processes, such as Laser Welding, Stringing, Staking, Heat Bonding, Injection Molding, Vision Systems, general experience with automated equipment (PLC/Servos/Pneumatics/ Sensors), etc. • Experience with design of experiments (DOE) to characterize and optimize processes, as well as analyze the resulting data to draw meaningful conclusions. • Ability to identify areas of improvement in processes and develop strategies to optimize the efficiency, quality and/or yield of those processes that are being developed. • Understand and evaluate the risks associated with these manufacturing processes and develop ideas/solutions to minimize these risks. Also work with PFMEA methodology for risk analysis documentation. • Ability to collaborate with other engineers, scientists, and production personnel to achieve manufacturing process development objectives and solve problems effectively. Be able to effectively communicate technical concepts to a variety of audiences, both technical and non-technical, through reports, presentations, and other media. Quality System Requirement: In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. • Assures that appropriate resources (personnel, tools, etc.) are maintained to assure Quality System compliance and adherence to the client site Quality Policy. • Establishes and promotes a work environment that supports the Quality Policy and Quality System. Requirements • Engineering Bachelors Degree plus hands on experience in FDA regulated manufacturing sites if Medical Devices will be a plus. Requirements • Engineering Bachelors Degree plus hands on experience in FDA regulated manufacturing sites if Medical Devices will be a plus.
