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Manufacturing Engineer -

Job Code - EC0874

Manufacturing Engineer Ė Fort Lauderdale - Florida

The Manufacturing Engineer reports directly to the General Manager and will be responsible for the support of all internal manufacturing activities that include project development, validation, qualification and implementation of processes, methods and equipment. Strong process development capabilities are essential.

1. Bachelorís Degree in Engineering or equivalent (5 years in relevant experience)
2. Minimum of 1 year experience as a Manufacturing Engineer
3. Experience with functioning in a highly regulated environment with working knowledge of ISO 13485 and FDA requirements
4. Highly innovative with the ability to work on own initiative
5. Strong written and verbal communication skills
6. Strong problem solving skills
7. Background in designing fixtures/gages for manufacturing
8. Strong process development capabilities
9. Experience with:
a. CAD (SolidWorks preferred)
b. Data Analysis
c. Risk Analysis
d. Root Cause Analysis
e. Ability to apply statistical methods

1. Assist with the development of medical device products from concept through development, testing and manufacturing scale-up.
2. Establish and maintain manufacturing documentation and drawings.
3. Recommend and implement tooling and fixtures.
4. Support the manufacturing operations activities.
5. Design various fixtures and tools and produce detailed drawings using SolidWorks.
6. Develop and execute qualifications (IQ, OQ, PQ) of equipment and processes.
7. Provide training for production operators.
8. Coordinate Non-Conforming Material and CAPA activities with Quality Assurance.
9. Support design transfer of new products from R&D into Manufacturing.

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