Manufacturing Engineer 1
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Job Location:
Monthly Salary:
Posted on:
20 hours ago
Vacancies:
1 Vacancy
Job Summary
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.
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Jabil including its subsidiaries is an equal opportunity employer and considers qualified applicants for employment without regard to race color religion national origin sex sexual orientation gender identity age disability genetic information veteran status or any other characteristic protected by law.
Accessibility Accommodation
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 site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to 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.#whereyoubelong
Required Experience:
IC
Key Skills
- Lean Manufacturing
- Six Sigma
- CNC Programming
- Lean
- Machining
- Tooling
- CAD
- CNC
- Assembly Experience
- SolidWorks
- Kaizen
- Manufacturing
About Company
At Jabil we strive to be the most technologically advanced and trusted manufacturing solutions provider.
