Job Description

The Manufacturing Engineer I supports the Engineering Department in the planning, design, implementation, validation, and continuous improvement of manufacturing processes for medical devices. This role ensures that production systems comply with applicable regulatory and quality management system (QMS) requirements, while achieving targets for performance, reliability, safety, cost, and delivery.

The position focuses on analyzing manufacturing workflows, optimizing processes, and supporting compliant production operations in accordance with ISO 13485, internal procedures, and applicable regulatory standards.

Key Responsibilities

Manufacturing & Process Support

• Support daily manufacturing operations to ensure compliant, efficient, and consistent production of medical devices.
• Develop, document, and maintain assembly processes, work instructions, and standard operating procedures (SOPs).
• Perform and support high-level assembly (HLA) activities by interpreting engineering drawings, specifications, and procedures.
• Train production operators on approved processes, equipment usage, and GMP requirements.

Validation & Regulatory Compliance

• Support medical device process and equipment validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Ensure manufacturing processes comply with ISO 13485, Good Manufacturing Practices (GMP), and internal QMS requirements.
• Participate in change control activities to ensure regulated changes are reviewed, approved, and documented prior to implementation.

Quality & Continuous Improvement

• Support New Product Introduction (NPI) builds and process transfers in accordance with regulatory and quality requirements.
• Investigate product and process quality issues, perform root cause analysis, and implement Root Cause and Corrective Action (RCCA/CAPA).
• Assist in product evaluation, process characterization, and data collection for quality and regulatory purposes.
• Drive continuous improvement and cost reduction initiatives while maintaining regulatory compliance and product quality.

Equipment & Production Line Support

• Support preventive maintenance (PM) activities and maintain records for engineering tools, fixtures, and production equipment.
• Assist with production line reconfiguration and machine/workstation moves, including equipment installation, setup, and qualification.
• Ensure equipment and tooling are suitable for validated and controlled manufacturing environments.

Safety & Compliance

• Adhere to all safety, health, environmental, and company security policies.
• Ensure compliance with documentation, data integrity, and record retention requirements.
• Maintain effective communication with cross-functional teams including Quality, Manufacturing, and Engineering.

Required Qualifications & Experience

• Diploma, Advanced/Higher/Graduate Diploma, or equivalent in Mechanical Engineering, Mechatronic Engineering, or a related discipline.
• Minimum 2 years of experience in manufacturing engineering, preferably within a medical device or regulated manufacturing environment.

Preferred Knowledge & Skills

• Knowledge of medical device manufacturing regulations and standards, including ISO 13485.
• Hands-on experience supporting IQ, OQ, PQ, and validation documentation.
• Familiarity with GMP, risk management, and change control processes.
• Strong analytical, problem-solving, and documentation skills.
• Effective written and verbal communication skills.

Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, age, disability, genetic information, veteran status, or any other characteristic protected by law.

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Accommodation Statement

If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.