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Karen E. Warden
10-29-1996, 10:50 AM
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*
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_____________ / \
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.