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.
Essential Duties and 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 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.
- 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%
- 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&T, 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.
- Must be able to read and interpret complex engineering drawings
- Supplier Quality Engineering/auditing experience preferred
- Familiarity with PPAP, control plans and validation is preferred
- Experience in an FDA regulated environment (preferably Medical Device) or regulated industry beneficial.
- 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).
- 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.
- Previous experience at a Stryker production site highly preferred.
- B.S in Mechanical/Industrial/Electrical Engineering or related engineering discipline with minimum 5 years work experience.
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