Bachelor's in mechanical engineering or manufacturing engineering or equivalent
Minimum experience of 3 years in medical devices - Manufacturing Engineering.
Good Experience working on Process Validations (IQ, OQ, PQ)
Experience developing manufacturing processes and technologies, which includes process characterization
Experience working on PFMEAs
Experience performing Data analysis (Minitab)
Evaluate process and design alternatives based on Design for Manufacturability principles.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Skill:
Manufacturing process development and Eligible to workimization
Lean Manufacturing and Continuous Improvement
Process Validation and FMEA (Failure Mode & Effects Analysis)
Root Cause Analysis and Problem Solving
Tooling, fixture, and equipment design
Design for Manufacturability (DFM)
Production troubleshooting and equipment support
Quality systems knowledge (FDA, ISO 13485, GMP)
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Numbers & Facts
Location
Plano, TX
Skills
Communication Skillsunmatched
Continuous Improvementunmatched
Corporate Policiesunmatched
Data Analysisunmatched
Detail Orientedunmatched
Establish Prioritiesunmatched
FDA (Food and Drug Administration)unmatched
FDA Requirementsunmatched
Failure Mode and Effects Analysis (FMEA)unmatched
Follow Throughunmatched
GMP (Good Manufacturing Practices)unmatched
ISO (International Organization for Standardization)unmatched
Identify Issuesunmatched
Lean Manufacturingunmatched
Lynxunmatched
Machine Toolunmatched
Manufacturing Designunmatched
Manufacturing Engineeringunmatched
Manufacturing/Industrial Processesunmatched
Mechanical Engineeringunmatched
Medical Equipmentunmatched
Minitabunmatched
Multitaskingunmatched
Operations Processesunmatched
Organizational Skillsunmatched
Presentation/Verbal Skillsunmatched
Problem Solving Skillsunmatched
Process Developmentunmatched
Process Validationunmatched
Regulatory Requirementsunmatched
Root Cause Analysisunmatched
Time Managementunmatched
Writing Skillsunmatched
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