COMPANY NAME: AEGEA Medical, Inc
Redwood City, CA 94063
TITLE: Senior Engineer or Project Manager
SUMMARY: The Company is developing a novel
energy delivery system for women’s health. The
system consists of a resusable hardware “box” and
a disposable hand-piece. The hand-piece is
designed and fabricated in house. The hardware
box was designed by an outside vendor and
contains mechanical elements, fluid pathways,
electronics and programmable software, The
company needs help to upgrade and transfer the
hardware box from the development house to a
manufacturer in order to have it built under a quality system.
Purpose of Job: Direct the design and
development efforts for the Company’s reusable hardware box.
Essential Functions:
• Support R&D’s efforts by
providing engineering services, project management and vendor oversight.
• Ensure integration with the
disposable device and the requirements of the medical procedure.
• Plan, schedule and complete
projects in an aggressive manner consistent with corporate objectives.
• Manage the design control
process by contributing to design discussion,
development of Hardware and Software
specifications, creation and documentation of
design information, and facilitating meetings.
Responsible for developing and populating DHF’s for projects.
• Ensure project documents,
processes and capabilities are complete and
current and that they comply with Quality Systems and Regulatory requirements.
• Work with management, vendors,
and advisors to ensure that development projects
are consistent with Company’s strategy and goals.
• Interface with and manage
outside vendors, consultants and suppliers. Must
be willing to travel to accomplish these tasks.
• Support clinical cases and clinical trial duties as needed.
• Actively work to promote team
building and morale within the department.
Job Requirements
• Bachelors in Engineering, preferably MSME or MSEE
• Minimum 8 years experience in medical device industry
• Demonstrated experience
managing medical device projects involving
outside suppliers through clinicals/commercialization
• Previous track record
developing software controlled medical devices.
• Leadership skills and judgment
to direct R&D efforts through the full cycle of
developing and delivering a PMA medical device to market
• Strong knowledge and practical
application of FDA QSR’s, design control process,
verification and validation testing, DHF construction and execution.
• Understanding of IEC 60601
Electrical Safety and EMC requirements.
• Strong interpersonal and communication skills
• Team player with proven track record in start-up environment
PLEASE SEND US:
• A short cover letter showing your
interest and what you would bring to the position
• Resume
• Send to:
o Fax Number: 650/701-1126
o Email: <mailto:aegeamedical_at_gmail.com>aegeamedical_at_gmail.com
_________________________________
Mickie Pallari
AEGEA Medical Inc.
2686 Middlefield Road, Ste A
Redwood City, CA 94063
P: (650) 701-1125 x401
F: (650) 701-1126
On May 4, 2011, at 10:28 AM, Kristin Burns wrote:
>Dear Mickie:
>
>Thanks for your interest in posting job announcements to the Design community.
>
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>
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><mailto:kristin.burns_at_stanford.edu>kristin.burns_at_stanford.edu
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>Should you place anyone as a result of this
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>Sincerely,
>
>Kristin Burns
>Design Affiliates Program Administrative Director
>ME Design
>
>At 10:26 AM 5/4/2011, Mickie Pallari wrote:
>>Hi Kristin:
>>
>>I was referred to you from a colleague at our company, AEGEA Medical.
>>
>>We would like to post a job posting for a
>>Senior Engineer / Project Manager through Stanford's Job Listing.
>>
>>Can you please let me know what we need to do
>>to get this on Stanford's website?
>>
>>I would really appreciate it.
>>
>>Thank you!
>>_________________________________
>>Mickie Pallari
>>AEGEA Medical Inc.
>>2686 Middlefield Road, Ste A
>>Redwood City, CA 94063
>>P: (650) 701-1125 x401
>>F: (650) 701-1126
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Received on 2011-05-05 11:33:23