A new Job, ID: 285675 <http://www.ejobsville.com/display-job/285675> was
added at eJobsVille.com - For the Best Tech Jobs in Town
<http://www.ejobsville.com>

Title:  Engineering and Research Manager position at Seattle, WA  posted on
2014-11-14 18:37:13

Job Description:*Title: Engineering and Research Manager*
*Location: Seattle, WA*
*Type: Permanent*
*Job description*
The Engineering and Research manager is responsible for the oversight and
management of all engineering and research related activities.
Responsibilities will focus both on product design, implementation and
testing as well as manufacturing oversight and interface with
subcontractors. The Engineering and Research manager will have ownership of
the development and manufacturing of the client product, will oversee the
development of the product from prototype to commercial product, and
ultimately first sale.
*Essential Functions**:*
·        Lead product development activities at contract design &
manufacturing facilities. Interface with project teams and management at
contract facilities to align activities with program requirements.
·        Develop project plans, specifying goals, strategy, resource
priority, and identification of program risks. Oversee activities
throughout concept, development, verification, and launch.
·        Develop validation and verification strategies for engineering
projects. Assure project design and manufacturing deliverables are in
compliance with Quality System Requirements, and applicable Industry and
Regulatory Standards and Guidance Documents.
·        Design development and manufacturing plans with outside vendors.
·        Manage vendors currently engaged in development and manufacturing
functions.
·        Provide clear communication to internal organization of product
development activities, appropriate escalation of challenges to senior
management, and data driven issue resolution.
·        Provide medical device development expertise to resolve
engineering and technical issues.
·        Assist in identification of next generation product changes and
development of product portfolio.
·        Interface with physicians, marketing, sales, and clinical teams to
refine design inputs. Ensure customer inputs are incorporated and
maintained throughout the product development cycle.
*Desired Skills & Experience**:*
·        Bachelor’s Degree in engineering discipline (preferably mechanical
engineering), Master’s Degree desirable.
·        Minimum of 5+ years’ experience in the medical device industry, 8+
desirable.
·        Minimum 2+ product development and manufacturing projects
completed (from prototype to commercial sale).

   - Experience working with disposables and adhesive based products
   desirable.

*Skills/Qualifications*:
·        Quantitative modelling skills applicable to structural analysis of
microstructures (e.g. finite element mesh modelling).
·        Test and validation protocol and activity development for device
specification verification;
·        Excellent project management skills.
·        Expertise in the Product Development cycle, including design
review, risk management and testing/validation planning.
·        CAD drawing software (e.g. Solid works, Rhino etc.) for use in
drawing package development and submission to vendors.
·        Background in manufacturing of medical devices.



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