Title : Manufacturing Engineer
Duration : 12 Months
Location : Goleta, CA
Job Duties :
-Design of Experiments (DOE) and Statistical Process Control (SPC)
-Determines manufacturing operation requirements and process
parameters
-Develops product and process improvements
-Participates in internal supplier audits
-Participates in procedure writing and review
-Performs process and equipment validations
-Provides technical support to other engineers
-Reviews product performance data to identify trends
-Supports manufacturing, development, and implementation processes
-Utilizes FMEA within process development
-Ensures compliance with GMP's
-Generates documentation for engineering protocols and reports
-Writes engineering and manufacturing specifications
-Sustaining engineer support for Silicone/Injection Molding dept.
-Must have molding exp as well as knowledge of regulated med device
industry.
-Incumbent provides engineering guidance and project team leadership
for the design, development and optimization of products, processes,
tooling and/or equipment with guidance from senior engineering.
-Exercises judgment within generally defined practices and
parameters.
-Applies principles of Customer Focused Quality in daily activities in
order to meet and exceed internal and external customer requirements.
-Ensures all activities are in compliance with Quality System
requirements.
Project Management:
-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:
-With guidance from senior engineering, designs products, processes,
tooling and/or equipment that meet customer needs, technical design
goals and regulatory/quality requirements.
Optimization:
-Optimizes product, process, tooling and/or equipment design to
produce cost-effective, quality results within design specifications.
Analysis:
-Evaluates products and competitor products and technologies.
Documentation and Systems:
-Demonstrates thorough and practical knowledge of quality and
documentation systems by ensuring system requirements are met.
Presentations and Training:
-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.
Continuous Learning:
-Remains informed about current medical/technical procedures,
engineering and material trends by reviewing current literature for
technology application, and appropriate coursework.
Qualifications:
- M.S. degree in engineering, physics or science and 2+ yrs related
engineering experience in a mfg environ, med device industry
preferred.
-Or - B.S. in engineering, physics or science and 3+ yrs related
engineering exp in a manufacturing environment, medical device
industry preferred
- Demonstrated engineering field of expertise such as mechanical,
electrical, biomaterials
- 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
Skills:
Design of Experiments (DOE)
Statistical Process Control (SPC)
Internal Supplier Audits
Procedure Writing & Review
Process & Equipment Validations
Utilizes FMEA Within Process Development
Write Engineering & Manufacturing Specifications
AutoCAD
Pro Engineer
SolidWorks
MS Project
Molding Experience
Regulated Medical Device Industry Experience
Quality System Requirements
FDA GMPs, & ISO 9000 & Documentation Procedures
Technology, Materials Science or similar discipline
. Ability to interface effectively with representatives of suppliers.
Thank You,
Deepa Mukurala
Senior Business Recruiter
MOTORIA
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