Manufacturing Engineer

Job description

We’re seeking an experienced Manufacturing Engineer to support a major rebrand project within a regulated medical device environment. This role focuses on label revalidation, documentation redlining, and change management, ensuring smooth, compliant updates across production and quality systems.

Key Responsibilities

• Lead label and packaging revalidation as part of the rebrand.
• Redline and revise SOPs, specifications, and technical files.
• Develop and execute IQ/OQ/PQ validation protocols.
• Manage change control processes and documentation.
• Perform risk assessments (FMEA, hazard analysis).
• Collaborate with Quality, Regulatory, Ops, and R&D teams.
• Ensure compliance with FDA, ISO 13485, and related standards.
• Share best practices and support process improvements.

Requirements

• Degree in Mechanical, Manufacturing, or Industrial Engineering.
• 5+ years’ experience in medical device manufacturing.
• Proven expertise in label validation and document control.
• Strong knowledge of change and risk management tools.
• Self-driven with experience managing complex technical projects.

Preferred

• Lean Six Sigma (Green Belt+).
• Experience with Agile PLM, SolidWorks.
• Background in rebrands, product transfers, or label redesigns.
• Familiarity with FDA QSR, ISO 13485, EU MDR.