Mechanical Engineer- Medical Device-  

Join a medical device company in San Diego area that has an immediate need for a Mechanical Engineer with experience in the development of medical devices.

Job Summary
The candidate will design enclosures, pneumatics and other aspects of new medical device. Responsibilities include

Required Experience
 Working knowledge of fluidics, pneumatics, and biomaterials
 Minimum 5 years mechanical design experience.
 Industrial design experience preferred.
 Familiar with ISO 13485, MDD, and FDA Quality System Regulation
 Experience with design and production of injection molded parts
 Minimum 2 years experience with 3D cad systems, preferably SolidWorks
Other Requirements
 BS degree in Mechanical Engineering and minimum 5 years of work experience in the medical device industry.
 Must be a self motivated, innovative, results oriented team player.
 Must be a legal US resident
 Strong written and oral communication skills
 Knowledge of medical device development and risk analysis processes, a MUST
 Experience with FDA’s QSR, ISO 13485 and Medical Device Directive, a MUST
 MS Office fluency is a plus (MS Word, Excel, PowerPoint, Outlook.)

Key Duties and Responsibilities
 Working alongside other R&D team members and other cross functional groups, contribute to the design of new medical devices
 Design of injection molded parts, enclosures, product packaging and related operations.
 Provide technical support to Production and Inspection personnel.
 Generate product or process qualification protocols and test reports for product verification and validation testing and conduct product or process qualification testing.
 Responsible for the development of any text fixtures necessary for testing and qualification of products and processes.
 Generate drawings and specifications.
 Executes projects within performance, schedule, and budget constraints through all phases of product development, from planning stages through design, prototyping, testing, and release to production.
 Ensures design is thoroughly documented and meets performance, reliability, manufacturability, serviceability, and obsolescence immunity goals.
 Conducts Failure Modes and Effects Analysis (FMEA) on new designs and guides design choices to maximize reliability. Acquires required agency approvals such as, U.L., C.S.A. and IEC 60601 certifications.

Send a word resume to jthompson@tescareers.com

Jeff Thompson
TES, Inc
440-266-0022 ext 104

Contact Information:

Contact: Jeff Thompson
Email: jthompson@tescareers.com