Manufacturing Engineering Support

The purpose of this position is to lead, review, and contribute to validation planning, risk assessment, system requirements formulation, design specifications, qualification protocol, and remediation efforts. The person will act as a cross-functional, inter-business unit resource. As such, the incumbent must be technically competent in multiple disciplines including information technology, quality, and GxP processes. ? ? Medical devices technical transfer experience ? Creating, maintaining, and improving controlled technical documents such as prints, procedures, bill of materials and routers ? Developing and supporting a wide variety of processing applications such as machining, finishing, forging, casting, cleaning, heat treating, bonding, molding, etc ? Conducting feasibility study on advanced processes to estimate product cost and analyze capital equipment, capacity, and capability requirements ? Establishing and improving process methods which meet performance and quality requirements ? Developing, leading, and executing project plans and schedules for work activities ? Communicating (written and verbal) direction and project plans with appropriate personnel from other departments ? Evaluating multiple options to select the most appropriate processes and machining methods ? Leading equipment qualification or process validation project(s) ? Solving a variety of complex product and/or process performance issue ? Developing rationale to set new process performance and quality standards? Experience supporting medical device manufacturing ? Specific experience with process characterization, equipment IQ/OQ, process OQ, and PQ ? Specific experience with Test method Validation and Gage R&R? Experience with root cause analysis and problem-solving for both technical and process issues ? Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003Ability to lead and prioritize multiple medium-complexity project assignments and complete work in a timely manner ? Good problem-solving skills through the use of quality and statistical tools ? BOM & Router creation and update? Ability to read and understand engineering drawings ? Knowledge of basic quality tools, risk analysis (PFMEA), statistics (SPC), Critical-to Quality (CTQ) Analysis ? Knowledge of Quality System requirements, ISO and FDA requirements? Ability to effectively work within a cross-functional team to complete critical project tasks ? Demonstrates good written and verbal communication skills ? Experienced with control procedures, such as the Change Management System, Nonconformance Reports, Engineering Specifications, Corrective and Preventive Action (CAPA), and Work Instructions & Proficient with Statistical Process Control concepts, process development, CNC programming terminology, and tooling design concepts? Microsoft Office Suite and Project