Job Title: Manufacturing Engineer
Job Location: Plano, TX (Onsite)
Job Type: Long Term Contract
Pay Rate: $40/hr
Job Details:
Qualification:
- 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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