Senior Product Development / Manufacturing Systems Engineer
|Job Title:||Senior Product Development / Manufacturing Systems Engineer|
|Contact Name:||Dominik Aliamani|
|Job Published:||May 15, 2017 16:10|
This position will be within the R&D Department but includes interfacing with R&D,
Manufacturing, Process Validation and External Suppliers.
Reporting directly to the Project Team Lead the successful candidate will have the
responsibility for leading a team of 4 engineers to produce the necessary documentation
to complete Design Transfer of already designed products, including:
* Develop Component Specifications and Associated First Article Inspection Plans
for all Purchased Components
* Develop Material Specifications for Manufacturing Materials.
* Develop Specifications for Part Assembled Components.
* Develop Specifications for all in-house and externally produced labels (excluding
Key Skills & Actions Required
* Develop Component tolerances in agreement with R&D and Suppliers
* Tolerance Stack Up Calculations for sub-assemblies
* Perform and lead project activities including dFMEA, pFMEA, DoE, SPC, etc.
* Specify Process Validation Requirements
* Test Method Development
* Creation of Documentation suitable for the Design History File and Device
Education & Training & Demonstrable Skills
* A minimum of a four year college degree in engineering or science.
* Minimum of five or more years of demonstrated success in product design and
development engineering roles with increasing responsibility in an ISO 13485
and/or FDA regulated medical device product development environment, with
the following demonstrable success:
* Demonstrable success in transferring new product development projects from
design to manufacturing and to external suppliers.
* Strong interpersonal communication skills and presentation skills
* Strong client centered attitude and maximum flexibility in a rapidly changing
* Lean Six-Sigma experience - ideally Green Belt or Black Belt accreditation.
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