Contact Info: kim.francisco_at_medtronic.com<mailto:kim.francisco_at_medtronic.com>
R&D/Product Testing Manager, Medical Device
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: Minimum of eight (8) plus years related
technical work experience; Minimum of five (5) plus years project
and/or people management experience
Preferred Years Experience: Eight (8) or more years in medical
products field; Demonstrated success with management of technical
functions involving high technical depth of knowlege; Demonstrated
success with management of engineering professionals; Experience with
FDA regulations, GMP, ISO 9001, or ISO 9002 requirements; Experience
with design and manufacturing of medical products.
Position Description:
Lead a functional engineering team to design, develop and perform
electromechanical and hydrodynamic testing of heart valve
products. Proactively interact with cross-functional teams and other
functional units.
Position Responsibilities
* Lead the testing support for tissue heart valve product development
activities. Define group objectives and provide day to-day work
direction and coaching for subordinate project leaders, engineers and
technicians. Ensure group objectives are consistent with business
unit strategic and operational objectives. Ensure product
development schedules are met.
* Ensure Medtronic Structural Heart Business maintains
state-of-the-art laboratory equipment and highly trained personnel
for safety, performance and durability testing of new heart valve devices.
* Interfaces with project team leaders to ensure accurate and
sufficient resources for supporting the company's product development
programs according to set priorities.
* Personnel management. Must manage people who do not directly
report to them but who are involved in the project. Establish
objectives, provide work direction as needed, and evaluate progress
and results.
* Leads the development of product testing 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.
* Effectively communicates cross-functionally
Basic Qualifications:
* Extensive Project management skills.
* Experienced of product development, manufacturing, clinical,
regulatory and business management requirements.
* Strong track records of successful applied engineering development,
scientific research, and/or product development
* Demonstrated solid people management and development skills.
* Financial management skills.
* Influence/communication skills.
* Experienced in working with large cross-functional team environment
Demonstrated Knowledge and experience
* Strong technical foundation
* Demonstrated track record in successful management of an
engineering function
* 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
* Strong leadership skill and quality
* People management and development
* Excellent skills in cross-functional collaboration
* Good organizational structure understanding
* Strong strategic thinker and planner
* Sound judgment and logic
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Potential applicants should communicate directly with the contact
listed in the posting. Please do not "reply" to the posting messages.
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Received on 2011-06-15 06:35:48