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Project Engineer (Validation)

Company: The Judge Group Inc.
Location: portage
Posted on: May 3, 2021

Job Description:

Location: Portage, MIDescription: Our client is currently seeking a Project Engineer (Validation) for a 12 month + contract.Project information: Project involves assembly of small and large parts for complex electromechanical equipment including, PCBs, PCs, motors, lasers, belts, brakes, generators, batteries, X-Ray tubes and actuators, precision alignments and complex final alignments using CMM arms on systems with live electrical power.Responsibilities: The Project Engineer works within a cross functional team to execute various tasks within the manufacturing transfer process per associated timelines, quality requirements and budget. Works with current suppliers to understand how components and sub-assemblies are manufactured, review validation documents, conduct Supplier Quality evaluations in order to plan the transfer of manufacturing process to Stryker manufacturing sites or other new suppliers/contract manufacturers. Supports in planning, testing, validation work in the areas including: PCB manufacturing, injection molding, manual assembly, electrical design, floor layout, fixture design, DFM activities and testing equipment-to name a few. Checks and approves engineering drawings for technical completeness, clarity, tolerance stack analyses, conformance with standards, dimensional accuracy and the correct specification of materials and processes. Develops validation protocols for MSAs, OQ-P, PQ and executes runs. Provide feedback and redlines on manufacturing work instructions, layouts, and equipment. Work closely with other functional areas of the company to drive successful project implementation. Actively engages with Manufacturing Operations to evaluate existing process layouts in terms of new process integration, ensuring best utilization of floor space, minimized handling and optimum process flow. Travel to meet with suppliers within United States and possible International travel ~20-40% Preferred Qualifications: Self-starter with demonstrated efficient work methods, analytical & problem-solving skills and ability to handle multiple tasks in a fast-paced environment. Technical understanding of mechanical engineering drawing principles, including dimensioning methods, Theory and application of GD, types of datum systems, manufacturing and/or inspection jigs and fixtures, limits and fits, Surface roughness specification. Strong communication skills with the ability to effectively work cross-functionally and externally as required. Knowledge of manufacturing processes, materials, product and process design. Supplier Quality Engineering/auditing experience preferred Familiarity with PPAP, control plans, PFMEA is preferred Experience with managing Manufacturing transfer projects very beneficial Experience in ECR/ECN and systems such as onePLM, Windchill & SAP beneficial High level of PC Skills required. (MS Excel, Access, PowerPoint, MS Project). Preferred Experiences: Extensive experience in validations- MSA, OQ, PQ- protocol development and execution highly beneficial. Previous experience at a Stryker production site highly preferred. Experience in an FDA regulated environment (preferably Medical Device) or regulated industry beneficial. Experience in manufacturing and final testing of medical device products, specifically, mobile CT scanners including precision alignments such as tilt & wag, lasers, tube & collimator and DMS very beneficial. Familiar with the use of handheld multi-meter, hand tools, pin gauges, CMM arms, measuring devices such as digital calipers and torque drivers. Knowledgeable of electrical devices including AC/DC voltages, Digital Multi-Meters and power supplies. Hi Pot equipment a plus. Required Qualifications: B.S in Mechanical/Industrial/Electrical Engineering or related engineering discipline with minimum 5 years' work experience.Contact: eronan@judge.comThis job and many more are available through The Judge Group. Find us on the web at www.judge.com

Keywords: The Judge Group Inc., Portage , Project Engineer (Validation), Other , portage, Michigan

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