Ledgent · 7 hours ago
Manufacturing Engineer - Medical Devices
Irvine, CA
Contract
Onsite
Mid Level
$46.66/hr - $63.33/hr
3+ years expLedgent Technology is looking for a Manufacturing Engineer specializing in Medical Devices. The role involves supporting new product introductions, evaluating manufacturing outcomes, and implementing improvements while ensuring compliance with quality management systems.
AssociationHuman ResourcesInformation TechnologyOutsourcingRecruiting
Responsibilities
Supports NPI and new equipment/process introductions
Evaluates manufacturing outcomes and implements continuous improvements and cost efficiencies
Provide technical support for quality control, process improvement, equipment qualifications, and process validations
Operate within our client's quality management system (QMS) to produce and/or review documentation such as, inspection guide sheets, product drawings, dynamic control plans (DCPs), and standard operating procedures (SOPs)
2D drawing & GD&T knowledge
Create and manage Engineering Change Requests as well as product impact assessments
Manage Engineering Change Notices for process changes from creation to final approval
Demonstrate a general understanding of Product Part Approval Process (PPAP) & First Article Inspection (FAI) process
Periodically lead projects and processes; work with cross-functional teams to get these projects completed. Ability to multi-task between different projects and changes
Investigate Quality issues for root cause and recommend/implement corrective actions
Ability to oversee team members workload and provide support when issues arise
Work to support team members as both mentor/mentee when necessary
Qualification
Required
Bachelor's Degree in Engineering
3+ years' experience in a regulated production/manufacturing environment
Experienced work in a Quality Management System
Demonstrated interpersonal, communication and presentation skills
Demonstrate strong teamwork and time management skills
Ability to perform in and be challenged by a multi-disciplinary team-based environment
Preferred
UDI/MDD/MDR/UKCA Regulatory Compliance project experience
Company
Ledgent
Ledgent Finance & Accounting, a business line of Roth Staffing Companies, provides temporary, temporary-to-hire, direct hire, and executive search services for finance and accounting positions.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$12.5M2000-09-20Series A· $12.5M
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