Manufacturing Engineer
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.