Manufacturing Engineer

Location: Kalamazoo, MI Salary: Competitive Description: Our client is currently seeking a Manufacturing Engineer The role for the Manufacturing Engineer is to complete all the required activity to transfer operations from acquisitions to production facilities or Contract Manufacturers- following Quality and Manufacturing transfer procedures.Project information: Project involves setting up of a semi-automated assembly line involving complex electromechanical equipment including ozone generators, vacuum chambers, electrical panels of sterilizer units and in-line testing.Responsibilities: The Manufacturing 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. Provides microbial technical expertise during new product development activities, process modification studies and failure investigations regarding microbiological contamination control. Reviews Supplier Change notifications for impact to sterilization/microbial testing and establishes the change qualification approach where necessary. Provides microbiological technical expertise to the Purchasing department in the selection and certification of component vendors. Trouble-shoot and problem-solve sterilizer/sterilization/results matters/issues 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. Reports observations/problems clearly and concisely, recognizing and highlighting specific deviations. Provide feedback and redlines on manufacturing work instructions, layouts, and equipment. Provides on-going status reports including periodic reviews progress and evaluation of results to management. 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: Bachelor's Degree in microbiology or technical field, graduate degree a plus Technical understanding of mechanical engineering drawing principles, including dimensioning methods, Theory and application of GD&T, types of datum systems, manufacturing and/or inspection jigs and fixtures, limits and fits, Surface roughness specification. Supplier Quality Engineering/auditing experience preferred Familiarity with PPAP, control plans and validation is preferred Experience in an FDA regulated environment or regulated industry beneficial. Experience with managing Manufacturing transfer projects very beneficial Experience in ECR/ECN and systems such as onePLM, Windchill & SAP beneficial 6+ years of experience in the industrial microbiology field within the medical device or pharmaceutical industry Experience in sterilization process management including validation Experience in manufacturing and final testing of medical device products very beneficial. Familiar with the use of handheld multi-meter, hand tools, 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. Contact: This job and many more are available through The Judge Group. Find us on the web at www.judge.com