Manufacturing Engineer

Manufacturing Engineer, Battery Manufacturing Engineering, Optimus

Austin, TX | $-$ | 5 days ago

• Execute end-to-end manufacturing and site transfer projects, including planning, risk assessment, validation, and handover.
• Coordinate all technical documentation, process flows, and equipment readiness activities at both sending and receiving sites.
• Support process and equipment validation (IQ/OQ/PQ) and ensure compliance with FDA and ISO 13485 requirements.
• Partner cross-functionally with Quality, Regulatory, Supply Chain, Manufacturing, and R&D to ensure alignment and readiness.
• Lead root cause analysis and technical problem-solving throughout the transfer lifecycle.
• Prepare and maintain project documentation, including validation protocols, reports, and change control packages.
• Communicate project progress, risks, and mitigation strategies to stakeholders at all levels.
• Capture and share lessons learned to continuously improve future transfer processes.

• Bachelor's degree in engineering, science, or related discipline.
• Minimum of 4 years of experience in medical device manufacturing or other regulated industries.
• Proven track record leading or supporting site or manufacturing transfers.
• Proven track record of new product launches into existing sites.
• Strong knowledge of process validation, change control, and manufacturing documentation.
• Excellent problem‑solving, communication, and organizational skills.
• Ability to work independently and drive results with minimal supervision.

• Experience with orthopaedic implants, instruments, or precision assembly.
• Familiarity with lean manufacturing and Six Sigma methodologies.
• Proficiency with ERP, PLM, or MES systems.

Associate

Contract

Pharmaceutical Manufacturing