Mechanical Engineer - 4157

Mechanical Engineer needed in Goleta, CA - We Want to Talk to you!

BB4101/4157

9months +

Positions: 2

Start Date: 1/13/2014 

End Date: 10/10/2014

Job Description

Job Duties: 

Create detailed product design specifications that meet customer requirements

Communicate design concepts and technical plans effectively

Lead troubleshooting activities of design issues

Conduct technical design reviews and presentations

Create design verification and validation plans, design fixtures for testing and direct clinically relevant testing to meet requirements

Write detailed protocols and reports

Review drawings, create ECO's

Demonstrated aptitude in mechanical engineering with hands-on experience in product design and development 

Skill Sets:

Required:

Education Level:

Undergraduate Degree

High School Diploma or Equivalent

Industry Experience: Greater than 5 Years

Senior R&D Engineer - BS in Mechanical, Biomedical, or Material Science with 5+ year's experience

MS in Mechanical, Biomedical, or Material Science with 3+ year's experience

At least some experience in Medical Device development desirable

Familiarity/knowledge of regulatory guidance for Design Controls for Medical Devices including ISO 13485, MDD, CFR 820

Understanding/experience with design history files, design control procedures, and design reviews a definite plus.

Will support MCARE project approximately 9 months duration.

Duties and Responsibilities:

Project Management:

1.Leads engineering projects of moderate complexity. Utilizes team leadership skills to effectively communicate, facilitate, and organize project activities. Develops and manages project schedules to ensure deadlines are met. Provides input to senior engineering for creating project budgets and identifying necessary resources.

Design:

2.With guidance from senior engineering, designs products, processes, tooling and/or equipment that meet customer needs, technical design goals and regulatory/quality requirements.

Optimization:

3.Optimizes product, process, tooling and/or equipment design to produce cost-effective, quality results within design specifications. Analysis:

4.Evaluates products and competitor products and technologies.

Documentation and Systems:

5.Demonstrates thorough and practical knowledge of quality and documentation systems by ensuring system requirements are met.

Presentations and Training:

6.Conducts presentations and explains technical information to management, employees and visitors in a manner that is easily understood. Provides technical training for other employees.

Safety:

Readily identifies safety issues in the immediate work environment and other work areas and recommends and implements solutions for improvement Reports directly to the Management of Engineering. Successfully interfaces with employees in R computer aided drawing and project scheduling software preferred

-Working knowledge of Quality System requirements, including FDA GMPs, and ISO 9000 and documentation procedures; ability to learn MPSM systems quickly