Manufacturing Engineer

Job Title

Responsibilities:

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.

Requirements:

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.

Preferred Qualifications:

Experience with orthopaedic implants, instruments, or precision assembly.

Familiarity with lean manufacturing and Six Sigma methodologies.

Proficiency with ERP, PLM, or MES systems.