Manufacturing Engineer

Job Summary

• The Manufacturing Validation Engineer will support medical device manufacturing operations by planning, executing, and documenting process, equipment, and measurement system validations.
• This role ensures compliance with ISO 13485, GMP, and 21 CFR Part 820 requirements while partnering with cross-functional teams to qualify equipment, improve processes, and maintain a validated state.
• The engineer will be responsible for creating validation protocols (IQ/OQ/PQ), performing statistical analysis, supporting calibration/metrology activities, and resolving validation-related quality issues.

• Perform process validation planning, execution, and reporting according to regulatory and internal requirements.
• Create and maintain validation documentation, including IQ, OQ, and PQ protocols and reports.
• Develop manufacturing documentation such as work instructions and standard operating procedures (SOPs).
• Collaborate with Manufacturing, Quality Assurance, Regulatory Affairs, and Equipment Engineering for machine qualification and change controls.
• Conduct calibration, metrology, and Gauge R&R studies ensuring full traceability of measurement equipment.
• Analyze process data using statistical tools (e.g., Minitab, JMP) to evaluate Cp/Cpk, repeatability, and process control.
• Review and approve validation reports and ensure timely closure of deviations, CAPAs, and non-conformances.
• Support design and development activities by applying GD&T principles and understanding medical device manufacturing processes.
• Maintain compliance with ISO 13485, GMP, 21 CFR Part 820, and risk management (ISO 14971).

• Bachelor's degree in Mechanical engineering, Manufacturing Engineering, Biomedical Engineering, or a related discipline.
• 25 years of experience in medical device manufacturing or regulated environments (Med Tech, pharma, healthcare devices).
• Hands-on experience with process validation (IQ/OQ/PQ) and manufacturing process documentation.
• Strong technical writing experience for validation documents and SOPs.
• Experience in metrology, calibration, and measurement system analysis (Gauge R&R).
• Knowledge of CNC machines, CAM software, and basic CNC programming.
• Proficiency with statistical software such as Minitab or JMP.
• Experience with document control and eQMS systems (Master Control, ETQ, etc.).
• Strong communication skills with the ability to present findings to cross-functional teams.