Note: The job is a remote job and is open to candidates in USA. Pyramid Consulting, Inc. is recruiting for a confidential client in the medical equipment manufacturing industry. The Mechanical Engineer will optimize manufacturing processes, support production at contract manufacturers, lead manufacturing projects and change control, validate processes, resolve quality and compliance issues, and create training materials and project plans.

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

Skills

• 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
• 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
• Experience with Windchill PLM and mechanical CAD tools such as SolidWorks or Creo

Benefits

• Health insurance (medical, dental, vision)
• 401(k) plan
• Paid sick leave (depending on work location)
• Remote work (U.S.)

Company Overview

Company H1B Sponsorship