US-CA, Senior Mechanical/Project Engineer, ENTERPRISE RECRUITING
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JOB TITLE: Senior Mechanical/Project Engineer
LOCATION: San Diego, US-CA
JOB TYPE: Direct
SALARY : $85000 - $95000
DESCRIPTION:
Senior Mechanical Engineer responsible for guiding the development of .’s
innovative medical devices. The products range from electromechanical medical
devices that provide oxygen for patients to other products and components that
use .’s gas separation technology. Responsible for generating and managing
innovative designs through creativity and awareness of state-of-the-art design
and manufacturing technologies using the latest solid modeling tools. Extensive
system integration experience and designing plastic molded components and
assemblies is a must. Additional experience with die-casting, extrusions,
rubber-molding and electromechanical systems is a plus. This position works
closely with Quality, Manufacturing, and Marketing to ensure that the product
meets its design requirements. Must be able to multi-task and maintain correct
priorities while coordinating with various departments, contractors and
overseas suppliers. Previous work experience should include Medical Device
Design for low cost, high volume manufacturing and expertise with FDA, QSR/GMP,
ISO, UL/CSA/IEC/CE regulatory requirements as well as familiarity with
electrical and product safety standards.
DUTIES AND RESPONSIBILITIES
• Manage outside design firm in the development
• Propose and develop innovative new design approaches utilizing new materials
and/or manufacturing technologies for ultra-low cost products and rapid
manufacturing assembly.
• Develop system level product specifications and detailed component
specifications.
• Work with suppliers to develop new sources of low cost components for
products.
• Ensure the design of all products comply with the necessary regulatory
agencies.
• Ensure that all the design activities comply with the . Quality System
procedures.
• Write and conduct Design Verification/Validations tests and write summary
test reports.
• Act as a liaison between . engineering and design consultants to solve
unforeseen design problems in the development phase of the project.
• Assist in the feasibility testing process and provide in-depth failure
analysis, documentation and reporting to development team and upper management
as required.
• Generate Engineering Change Orders via Microsoft, AutoCad and Solidworks
applications.
• Assist in manufacturing transfer interface by work with Manufacturing
Engineers to ensure smooth design transfer into production at overseas contract
manufacturer.
Core Competencies:
• Experienced system integrator with DFA/DFM for medical, low-cost, high volume
products.
• Highly proficient with 3D modeling, SolidWorks experience preferred.
• Experienced with compressors, heat exchangers, fans, valves, motors and
gearboxes.
• Knowledgeable in New Product Development Methodologies.
• Skilled at Quality policies, procedures/systems, ISO 9000.
• Understand and follow Design Controls, Engineering Change Control and Product
Validation.
• Good written and oral communications in English, able to speak Chinese as
well is a plus.
• Self-disciplined, motivated, astute problem solving skills.
• Dedicated team player requiring minimal supervision.
• Detail oriented.
• Experience with Medical Device Design highly desirable.
TRAINING AND EXPERIENCE
• Bachelor’s degree/Master’s Degree preferred.
• 7+ years of experience as a Senior Engineer
PHYSICAL REQUIREMENTS
• Ability to lift 25lbs, move parts using a pallet jack.
• Must be able to read & write in English.
• Good hand / eye coordination.
• Full range of motion in upper body.
MANDATORY SKILLS:
MANDATORY EDUCATION: Bachelor of Science
Please refer to Job#: 01292670-TE in all correspondence about this job.
ENTERPRISE RECRUITING
John DeMaio
Apply for this Job, please click on the link below.
http://www.topechelon.com/applyjob.asp?JobID=01292670NG
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