Sr. Staff/Principal Reliability/Test Engineer Zeltiq Aesthetics, Inc.
THIS JOB HAS EXPIRED Description
Description: Analyzes preliminary engineering-design concepts of next generation. Designs and implements test fixtures and methods to determine operational reliability, using knowledge of mechanical, electrical, fluid and systems engineering. Expected to be hands-on with respect to test design and execution.
Reports To: Sr. Director of Design Engineering
Principle Responsibilities and Duties:
Note: The following is meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.
Reviews engineering specifications and drawings, proposing design modifications under the auspices of identifying potential components whose Reliability may be in question.
Works closely with other departments and outside entities, e.g. vendors and contract resources, to project what kinds of components need to have their Reliability assessed
Designs, implements, and debugs electromechanical test fixtures incorporating fluidics, pneumatics, motor control, data acquisition, etc. to assess component and system-level reliability.
Creates test plans, protocols, and reports to support reliability and test activities.
Supervises testing at outside labs in support of mechanical stress (e.g., shock/drop/vibration) and environmental.
Stays up-to-date with the design activities that are in progress in designing the next generation product.
Responsible for performing all duties in compliance with FDA?s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies.
Experience, Education, Training, Traits:
BSEE or BSME plus ten years experience in engineering of medical devices.
Extensive experience designing electro-mechanical test fixtures incorporating data acquisition and automated control (e.g., using LabView with National Instruments interface boards).
Must be strong hands-on contributor, able to work independently with little supervision.
Experience in prospectively determining Reliability programs for new products.
Experience in designing and performing reliability testing including Mechanical Stress Tests, Shock/Drop/Vibration Testing, Environmental Testing
Must be intuitive and forward thinking to identify components for Reliability testing of the design, even though it is not yet finalized.
Ability to use fundamental failure analysis methodology to derive a root cause of failures observed.
Provide design input to improve product reliability based upon testing and engineering knowledge.
Experience in designing or servicing systems or parts of systems that require basic knowledge in the areas of fluidics, thermal managment, sheet metal design, adhesives technology, electronic circuitry, flex circuits, connectors, cables, part design, packaging and manufacturing assembly processes.
Attention to detail with respect design and documentation.
Proven track record of successful project management and familiarity with project scheduling software such as MS Project.
Ability to focus and achieve scheduled milestones, including contingency planning.
Knowledge of FDA Quality Systems including Design Control and documentation.
A drive to get the job done in the face of obstacles and time constraints.
Ability to reach out into the organization for assistance and resources when needed.
Ability to motivate teams and individuals.
Ability to multi-task in an entrepreneurial environment.
Experience using 3D modeling software, and in particular Pro-E, strongly preferred.
Language and Verbal Skills
Ability to read, analyze, and interpret engineering specifications, technical procedures and vendor data sheets or instructions
Ability to write reports, specifications, procedures, and business correspondence.
Ability to effectively present information and respond to questions from groups or managers
Ability to clearly and concisely convey project accomplishments, obstacles, issues and status to project team members
||Pleasanton, CA |
THIS JOB HAS EXPIRED