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  • POSITION ANNOUNCEMENT

    I am posting this notice as a favor ... Please do not respond to me, but
    rather to the address at the end of this posting.

    Thanks, Karen*
    -- __
    _____________ / \
    Karen E. Warden \ /__/ |_
    Orthopaedic Engineering Lab | / \
    Case Western Reserve University | / \
    Cleveland OH, USA | _ |_ \
    kxw15@po.cwru.edu /____________\ \ \ \ |
    \__\ \___/


    POSITION ANNOUNCEMENT: DIRECTOR OF ENGINEERING

    Omeros Medical Systems, Inc., a Seattle based firm, was formed in
    June 1994 to develop and commercialize (1) novel surgical/orthopedic,
    implantable devices and (2) proprietary therapeutic approaches to the
    management of surgical pain and inflammation, vasospasm, smooth muscle
    spasm and vascular restenosis. Omeros is privately financed by
    accredited investors.

    In order to support the growing product development initiative
    addressing its surgical/orthopedic implantable devices, Omeros is
    actively recruiting a Director of Engineering. This position will report
    to the President. The "Position Description" is as follows:

    DIRECTOR OF ENGINEERING

    Summary of position goals and responsibilities:

    This position will support the Company's engineering and product
    development initiative in the area of implantable bioabsorbable
    orthopedic devices, and will require engineering management, product
    development, design analysis, project planning, FDA process management
    and engineering team building. Additional responsibilities include: (1)
    the identification, negotiation, and management of outside engineering
    organizations, which will be engaged to support the Company's
    engineering programs; and (2) the representation of the Company's
    engineering and manufacturing interests in corporate partnerships and
    licensing agreements.

    Education:

    M.S/Ph.D. Engineering preferred; ideally, the candidate would have
    breadth of experience including biomechanics, polymer-based technology.
    product design and instrument ergonomics,

    Business Experience to include:

    * Senior management experience combined with effective communication
    skills at all organizational levels; demonstrated success in leadership
    of both 'in-house' and contracted engineering relationships
    * Polymer based products - surgical application instrument design
    and development engineering, manufacturing transfer and documentation
    support
    * Direct participation in alpha product conceptualization through
    refinement stages into beta and clinical prototypes; refinement of
    product specification based on laboratory and clinical testing
    * Development of testing protocols in support of regulatory
    guidelines; development experience in both 510(k) and PMA regulatory
    environments
    * Membership in cross-discipline development team, including
    coordinated communication and management with: Product Management,
    Manufacturing, Clinical Testing/Trial Sites (human and animal), Key
    Physicians and Corporate Partners
    * Development of engineering team; proven ability to identify and
    attract key engineering talent
    * Direct medical manufacturing and quality assurance experience in
    both plastic components and fabricated, reusable surgical application
    instruments
    * Device and instrument sterilization process and FDA validation
    standards
    * Packaging design; point of use and humidity/temperature sensitive
    storage

    Technical Proficiency:

    AutoCAD 13 & 12 of equivalent, UniGraphics workstation, Microsoft
    Office suite and Win95

    Regulatory Proficiency:

    FDA submittal support (PMA & 510k), engineering documentation, GMP
    manufacturing standards and ISO 9001 international standards

    Mail resume to the attention of: Linda Madison; Omeros Medical Systems,
    Inc.; 2203 Airport Way South, Suite 405; Seattle, Washington 98134.
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