Description
Mechanical Engineer needed in Goleta, CA - We Want to Talk to you!
BB
9months +
Positions: 2
Start Date:
End Date:
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&D, Marketing, Sales, Manufacturing, Special Products, Inventory Control, RA/Quality, Purchasing, Machine Shop and QC as well as outside vendors and other client employees.
-M.S. degree in engineering, physics or science and 3+ years related engineering experience in a manufacturing environment, medical device industry preferred or
-B.S. degree in engineering, physics or science and 5+ years related engineering experience in a manufacturing environment, medical device industry preferred
-Demonstrated engineering field of expertise such as mechanical, electrical, biomaterials, etc.
-Demonstrated ability to effectively manage projects of moderate complexity
-Demonstrated ability to solve a wide range of moderately complex engineering problems in creative and practical ways -Demonstrated team leadership skills
-Demonstrated excellent interpersonal skills
-Demonstrated excellent organizational skills. Demonstrated excellent verbal and written communication skills including ability to effectively develop and present technical information necessary for the company
-Demonstrated excellent analytical skills
-Familiarity with personal computer software including word processing, spreadsheet, and statistical programs; 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