Sr Manufacturing Engineer

Sr Manufacturing Engineer Location: San Francisco, CA (Onsite – 5 days a week) Duration: 6+ months contract IRC: IRC289521 Medical device experience is mandatory. Job Description Desired Qualifications: SolidWorks or similar 3D modeling and design experience. Project leadership/management experience and/or leading a team. Knowledge of Lean and Six Sigma concepts and root cause problem solving. About You: Bachelor’s Degree in Engineering or a related field required; Master’s degree preferred. Must have at least 5+ years of related experience in the medical device or similar field. Experience with Continuous Process Improvement and Process Validations within a medical device manufacturing environment. Strong creative and critical thinking skills. Ability to work in a fast-paced, cross-functional environment. Some travel may be required – must be able to travel within the US. Experience working in ISO 13485 and FDA regulated environments. Job Responsibilities Responsibilities include: Support of new and existing manufacturing processes, new products, product changes and enhancements, as well as related tooling and fixtures. Support prototype and pilot production, facilities, and planning, when appropriate. Interfaces with other departments to solve production problems. Investigation and testing of product processes. Lead manufacturing efforts associated with new product transfer between R&D and manufacturing. Drafts and executes validation of product, equipment, and processes. Manages builds for new product development in prototype and pilot production setting, including training of operators and coordination with production planning as needed. Analyze data and improve processes to assure robust/repeatable manufacturing processes. Confers with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems and develop processes. Review and/or develop manufacturing and engineering documents. Provide solutions to complex problems including, but not limited to, those related to process, equipment, material, supply chain, documentation, equipment validation, IQ/OQ/PQ, PLM, and other applicable QMS / business processes. Perform root cause analysis and implement process improvements to improve manufacturing yield. Support the design and development of tooling and fixtures to effectively manufacture new and existing products. Searches and implements new technologies to improve manufacturing processes and equipment design. Demonstrated analytical skills with the ability to present data in meaningful and relevant fashion to aid in decision making process. Establish and maintain data monitoring for key processes metrics in manufacturing. Excellent written and verbal communication skills. #J-18808-Ljbffr