Staff Mechanical Engineer Zeltiq Aesthetics, Inc.

Description

As a key contributor in an expanding advanced development team, this individual will explore new product concepts and demonstrate feasibility of new medical devices and procedures. Areas of focus for the Product Innovation team include new approaches to CoolSculpting devices and procedures, as well as active exploration and initial development of several other promising new aesthetic and therapeutic medical device opportunities.

Duties will span a broad range of activities, from initial brainstorming sessions, to design, fabrication and testing of concept prototypes, through support of early human clinical testing.
Essential Duties and Responsibilities include the following (other duties may be assigned):

Participate in and/or lead brainstorming sessions.

Research and analyze specifications and test data to determine merit and feasibility of new product concepts.

Analyze heat transfer, fluid flow, power requirements, and system efficiency.

Document design concepts and technical progress in lab notebooks and patent disclosures.

Design, build, and test concept prototypes.

Analyze data and experimental uncertainty.

Draw conclusions based on limited data.

Write formal technical reports documenting test fixtures, methods, results, analysis, and conclusions.

Identify and manage technical risks.

Present technical achievements to peers and to management.

Apply risk management and design control procedures as required in the development and testing of human clinical test prototypes.

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.
Qualifications:

BS/MS in mechanical engineering with 10+ years product development experience, including 5+ years medical device experience.

Ability to define problems, collect data, establish facts, and draw valid conclusions and recommendations.

Strong analytical skills in fluid dynamics and heat transfer.

Experience with computational fluid dynamics and thermal analysis tools to predict prototype performance highly desirable.

Parametric solid modeling CAD experience (5-years Pro/E experience preferred).

Hands-on test fixture design, assembly, and bench testing skills and experience.

Strong technical report writing skills.

Ability to focus on achieving scheduled milestones.

Ability to work collaboratively in a dynamic cross-functional environment.

Ability to clearly and concisely convey project accomplishments, issues, and status to project team members.

Knowledge in ISO and FDA quality systems regulations and medical design and development lifecycle.
Additional Requirements:

Self motivated and technically creative with proven ability to identify and prioritize technical risks and develop innovative solutions.

Experience with project planning, work breakdown structures, and accurate estimating of task durations in the creation of project schedules

Competent using MS Office including Word, Excel.

Occasional travel (typically

Location:	Pleasanton, CA United States