Bachelor's degree in engineering (Mechanical/Electrical/Biomedical/Manufacturing) or equivalent experience with 3+ years' experience.
Strong understanding of IQ/OQ/PQ methodologies and validation lifecycle.
Knowledge of medical device regulations (FDA, ISO 13485).
Experience in manufacturing processes, equipment qualification, and process validation.
Familiarity with GMP, CAPA, and change control processes.
Ability to read and interpret engineering drawings, P&IDs, and technical specifications.
Strong problem-solving and analytical skills.
Excellent communication and documentation skills.
Responsibilities
Execute and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for manufacturing equipment and processes.
Develop, review, and execute validation protocols and reports in compliance with FDA and regulatory standards.
Coordinate with cross-functional teams (Quality, R&D, Production, and Validation teams) for successful validation execution.
Support equipment installation, commissioning, and troubleshooting activities.
Ensure adherence to Good Manufacturing Practices (GMP) and quality systems.
Perform risk assessments (FMEA) and contribute to process improvements.
Maintain accurate documentation, traceability, and validation records.
Benefits
Full-time onsite role in a regulated medical manufacturing facility.
Collaborative work environment with cross-functional teams.
Full Job Description
Job Description: Role Summary:
The Manufacturing Engineer will support equipment and process validation activities (IQ/OQ/PQ) for a medical device production facility.
The role involves ensuring that manufacturing systems, equipment, and processes meet regulatory, quality, and performance standards while supporting production readiness and compliance.
Key Responsibilities:
Execute and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for manufacturing equipment and processes
Develop, review, and execute validation protocols and reports in compliance with FDA and regulatory standards.
Coordinate with cross-functional teams (Quality, R&D, Production, and Validation teams) for successful validation execution.
Support equipment installation, commissioning, and troubleshooting activities
Ensure adherence to Good Manufacturing Practices (GMP) and quality systems
Perform risk assessments (FMEA) and contribute to process improvements
Maintain accurate documentation, traceability, and validation records
Participate in process optimization and continuous improvement initiatives
Support audits, inspections, and regulatory submissions as needed
Required Skills & Competencies:
Bachelor's degree in engineering (Mechanical / Electrical / Biomedical / Manufacturing) or equivalent experience with 3+ years' experience
Strong understanding of IQ/OQ/PQ methodologies and validation lifecycle
Knowledge of medical device regulations (FDA, ISO 13485)
Experience in manufacturing processes, equipment qualification, and process validation
Familiarity with GMP, CAPA, and change control processes
Ability to read and interpret engineering drawings, P&IDs, and technical specifications
Strong problem-solving and analytical skills
Excellent communication and documentation skills
Preferred Qualifications:
Experience in medical device or regulated manufacturing environment
Exposure to cleanroom manufacturing environments
Familiarity with statistical tools and validation software
Experience supporting automation systems or complex manufacturing equipment
Work Environment:
Full-time onsite role in a regulated medical manufacturing facility
Requires collaboration with cross-functional teams and shop-floor presence
Key Deliverables:
Approved IQ/OQ/PQ protocols and reports
Equipment qualification and validation documentation
Compliance with regulatory and quality standards
Timely execution of validation and production readiness activities
