Electro-Mechanical Engineer

Immediate need for a talented Electro-Mechanical Engineer. This is a 06 - 12+months contract opportunity with long-term potential and is located in Irvine, CA (Hybrid). Please review the job description below and contact me ASAP if you are interested.

Job ID: 26-28738

Pay Range: $35/hr - $47/hour.  Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design to ensure parts, equipment, tools, fixtures, etc. are up to standards
• Use technical principles, problem solving skills, and data analysis to support and problem-solve for production at contract manufacturer.
• Work and lead initiatives to support manufacturing projects and goals (material qualification, supplier/label/part/product changes, product enhancements, equipment qualifications, tolerance stack analysis through technical advancements, problem solving skills, and process excellence methodologies.
• Support key project initiatives (supplier transfers, part changes, system enhancements, line extensions, cost reductions, labor efficiency improvements, and quality and compliance excellence).
• Manage change control for ongoing manufacturing changes, including CAD updates, change requests, process changes, Device Master Record, product specifications, test processes, and product service processes.
• Deploy, review, and act upon meaningful metrics to measure, control, define, refine, and optimize processes and for process control and continuous improvement.
• Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
• Analyze and resolve complex manufacturing and compliance issues (e.g., CAPA, non-conformances, and audit observations)
• Develop training and documentation materials (e.g., work instructions) for production to enable seamless knowledge transfer of project and manufacturing processes
• Lead and establish project plans to ensure deliverables are completed to customer expectations using project management tools (e.g., project plans and risk analyses)
• Perform other incidental duties as assigned by leadership

Key Requirements and Technology Experience: 

• Electro-Mechanical LCM Engineer
• Bachelor’s degree in engineering or a related scientific field with at least 5 years of relevant industry or combined industry and academic experience; or
• Master’s degree in engineering or a related scientific field with at least 4 years of relevant industry or combined industry and academic experience; or
• Ph.D. in Engineering or a related scientific field with relevant industry or academic experience.
• Experience with Windchill PLM
• Experience with mechanical CAD tools such as SolidWorks, Creo, or Pro/ENGINEER
• Teamcenter PLM
• Familiarity with medical device quality systems and regulations, including ISO 13485 and 21 CFR Part 820
• Lean Champion or Six Sigma certification
• Bachelor’s degree in engineering or a related scientific field with at least 5 years of relevant industry or combined industry and academic experience; or
• Master’s degree in engineering or a related scientific field with at least 4 years of relevant industry or combined industry and academic experience; or
• Ph.D. in Engineering or a related scientific field with relevant industry or academic experience.
• Proficiency with Microsoft Office applications, including Microsoft Project
• Ability to read electronic schematics and mechanical drawings
• Experience with Windchill PLM
• Experience with mechanical CAD tools such as SolidWorks, Creo, or Pro/ENGINEER
• Strong technical writing, documentation, presentation, and verbal communication skills
• Demonstrated analytical, problem-solving, critical-thinking, and organizational skills
• Demonstrated strong accountability and ownership, with a proven ability to take responsibility for commitments, proactively drive work to completion, and follow through on deliverables
• Working knowledge of statistical methods, engineering principles, manufacturing processes, process controls, and production equipment
• Ability to manage multiple priorities and work effectively with cross-functional teams in a fast-paced environment
• Demonstrated ability to lead initiatives, influence change, and collaborate with internal teams, suppliers, and senior stakeholders
• Strong attention to detail and commitment to quality, compliance, and workplace safety
• Experience with Teamcenter PLM
• Familiarity with medical device quality systems and regulations, including ISO 13485 and 21 CFR Part 820
• Lean Champion or Six Sigma certification
• Experience troubleshooting finished devices, subassemblies, and component failures and documenting evaluation results
• Experience with clean-room manufacturing, laboratory, or industrial equipment.

Our client is a leading Medical Device Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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