Contact Info: kim.francisco_at_medtronic.com<mailto:kim.francisco_at_medtronic.com>
Minimum Education: BS in Technical, Mechanical or Biomedical
Engineering, or BS in related or other fields with appropriate
engineering course work/experience
Preferred Education: MS or PhD
Minimum Years Experience: 7 years of medical device R&D/product
development
Preferred Years Experience: 3-5 years in prosthetic heart valve
product development design and testing
Position Description:
Design and development of new and modified valve designs and/or
annuloplasty rings for medical applications in a regulated
environment. Activities will include project management,
methods/process development, design modeling, tooling
design/fabrication, equipment design/fabrication, qualification,
validation, and documentation. Leads development projects in
multi-functional project teams (as assigned).
Position Responsibilities:
* Design and implementation of new prosthetic heart valves, related accessories
* Concept generation and product specifications. Ensure review of
existing research, device concepts and data. Create new device
concept. Identify areas that require additional investigation. In
conjunction with product planning / marketing, collaborate with
leading physicians and experts for the purpose of identifying and
clarifying customer needs, plans, goals, and progress.
* Project management. Set project objectives and milestones with
initially complex or undetermined outcomes. Lead project
decision-making using customer input and knowledge of technical
feasibility. Provide project planning and management for these
multi-functional or cross-business projects.
* Personnel management. Must Ability to manage people who do not
directly report to them but who are involved in the project. (May or
may not have direct reports as well.) Establish objectives, provide
work direction as needed, and evaluate progress and results.
* Develops product specifications and process specifications.
* Specifies tests for product testing based on design specifications
and applicable guidelines (industrial and government guidelines
and/or standards).
* Performs data analysis (statistical and practical) and develops
appropriate action plans based upon such analysis.
* Communicates progress and decisions to associates and functional manager.
Basic Qualifications:
*Knowledge of United States and International regulatory requirements
(medical device, general), GMPs and industry standards/guidelines.
*Medical Design Control knowledge and experience
*Exceptional Design skills
*Computer Skills : CAD; Microsoft Word, Excel, Project, and
PowerPoint; LabVIEW; Matlab
*Excellent verbal and written communication skills
*Failure Analysis
*Custom instrumentation and laboratory automation skills
*Project management and planning
*Statistical methods
Demonstrated Knowledge and experience
* Strong technical foundation
* Demonstrated product development experience and track record
of taking products from concept to market release
* Demonstrated project management skills and leadership of
different project types and complexities
* Broad understanding of different aspects of product
development such as cross-functional collaboration and deliverables
from Marketing, R&D, Quality, Regulatory, Manufacturing, etc.
* Demonstrated experience in design control and medical device
regulations
* Excellent skills in cross-functional collaboration
* Excellent problem solving skills
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Potential applicants should communicate directly with the contact
listed in the posting. Please do not "reply" to the posting messages.
Job postings are archived at
http://design.stanford.edu/archive/ (the archive is not working
right now - we hope to have it fixed soon)
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Received on 2011-06-15 06:35:23