Job Description

We are seeking a skilled and detail-oriented Process Engineer with experience in process validation within the medical device industry . The ideal candidate will be responsible for developing, validating, and improving manufacturing processes in compliance with FDA, ISO 13485, and industry-leading quality standards. This role plays a critical part in supporting new product introductions, ensuring product quality, and maintaining regulatory compliance across all process development activities.

Responsibilities:

• Lead and execute process validation activities including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) according to regulatory and internal quality system requirements.
• Develop and maintain robust manufacturing processes for new and existing products through application of risk-based methodologies and engineering best practices.
• Prepare and review validation documentation, including protocols, reports, and traceability matrices.
• Drive continuous improvement initiatives using tools such as Design of Experiments (DOE), Root Cause Analysis (RCA), and Statistical Process Control (SPC) .
• Collaborate with cross-functional teams including Quality, R&D, and Production to support process design, troubleshooting, and optimization.
• Create and update process documentation such as PFMEAs, process maps, and control plans to reflect validated states.
• Support internal and external audits by providing validation documentation and technical justification for process decisions.
• Ensure adherence to Good Manufacturing Practices (GMP) and applicable regulatory guidelines , including FDA 21 CFR Part 820 and ISO 13485 .
• Analyze production data using statistical tools (e.g., Minitab, JMP) to evaluate process capability and identify areas for improvement.

Qualifications:

• Bachelor's degree in Mechanical, Industrial Engineering, or related discipline.
• 3-7 years of experience in a regulated medical device manufacturing environment.
• Proven experience in process validation (IQ/OQ/PQ) , with a strong understanding of documentation and regulatory expectations.
• Experience with risk management tools such as FMEA , as well as validation planning and execution frameworks.
• Proficiency in technical writing and documentation aligned with industry best practices.

Job Types: Full-time, Contract

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work Location: In person

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