Mechanical Engineer

Key Responsibilities

• Identify and implement opportunities to optimize manufacturing processes using engineering methods such as Six Sigma and LEAN.
• Utilize technical principles and data analysis to support production at contract manufacturers.
• Lead initiatives for manufacturing projects, including material qualification, supplier changes, and product enhancements.
• Manage change control for ongoing manufacturing changes, including CAD updates and product specifications.
• Develop and execute complex experiments to qualify and validate manufacturing processes, analyzing results and making recommendations.
• Analyze and resolve complex manufacturing and compliance issues, including CAPA and non-conformances.
• Create training and documentation materials to facilitate knowledge transfer of manufacturing processes.
• Establish project plans to ensure deliverables meet customer expectations using project management tools.

Key Requirements and Technology Experience

• 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 and clean-room manufacturing.
• 5+ years of relevant industry experience, or a Master's degree with 4+ years of experience, or a Ph.D. in Engineering or a related field.
• Proficiency with Microsoft Office applications, including Microsoft Project.
• Ability to read electronic schematics and mechanical drawings.
• Experience with Windchill PLM and mechanical CAD tools such as SolidWorks or Creo.
• Strong technical writing, documentation, and communication skills.
• Demonstrated analytical, problem-solving, and organizational skills.
• Proven ability to manage multiple priorities and work effectively with cross-functional teams.
• Strong attention to detail and commitment to quality and compliance.

Our client is a leading Medical Equipment Manufacturing 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.