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Account and Business Development Manager

Job Code - EC0875

Sr. Design Engineer Medical components Ė Ft. Lauderdale, Florida

The Senior Design Engineer reports directly to the General Manager and will be responsible for the successful design and development of medical device products. This position is responsible for all aspects of the product development cycle from product conception through development and manufacturing transfer within a start-up environment.

This position also requires project management responsibilities for multiple products and may lead or direct small teams in the design and development of medical device products. Strong communication and leadership skills are essential.

Employment Requirements
1. Bachelorís Degree or equivalent in Engineering
2. Minimum of 10 years experience in R&D or Product Development with 5+ years of Medical Device Design Experience
3. Experience with functioning in a highly regulated environment with exposure to ISO 13485 and FDA requirements
4. High innovative ability and motivation to work on own initiative
5. Strong written and verbal communication skills
6. Strong background of designing with Polymer materials; specifically medical grade plastics
7. Experience and proficiency with:
a. CAD
b. Geometric Dimensioning and Tolerance
c. Data Analysis
d. Risk Analysis
e. Root Cause Analysis
f. Application of Statistical Methods

1. The development of medical device products from concept through development, testing and manufacturing scale-up.
2. Design complex detailed part drawings and assemblies by using SolidWorks.
3. Strong understanding and experience with material selection in applications that must meet challenging requirements such as high stress, fatigue and sterilization compatibility.
4. Project Management responsibilities will include:
a. Directing Design
b. Chairing Project Meetings
c. Developing and maintaining project plans, schedules and budgets
d. Management of Service and Supplier in respect to directing design
5. Apply new technologies and processes to optimize product design and development methods and processes.
6. Create specification, define testing protocols, monitor or execute testing qualification in accordance with Design Control and Validation Process.
7. Perform engineering analysis such as Tolerance Studies, Finite Element Analysis and Design for Manufacturability.
8. Fabricate concept and working prototypes with the use of in-house manufacturing and rapid prototype sources.

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