Manufacturing Engineers (Medical Devices)
Optima Organizational Solutions
- Baja California
- Permanente
- Tiempo completo
**ACTIVITIES AND RESPONSIBILITIES**
- Establishes standards and policies for pollution control, installation, modification, quality control, testing, operating procedure, inspection, and maintenance of equipment and products.
- Conceptualize and institutes improvements to processes.
- Evaluates proposed improvements to processes and products based on analyses of regulatory requirements, product quality needs, ergonomics, safety, environmental and costs.
- Understands and utilizes the Quality System Requirements for design control and provides an appropriate engineering/technical assessment of data/documents supporting the design history file.
- Develops experimental design and statistical process control tools to assure process reliability, maintainability and safety.
- Evaluates fitness for use of materials, designs, processes, tests, and products.
- Design, execution, and analysis of experiments based on statistical techniques.
- Risk management development, troubleshooting and refinement of manufacturing processes and equipment.
- Performs and writes validations of product, processes and equipment in accordance with FDA, ISO and other applicable guidelines.
- Documents work via reports, technology notebooks, and design file entries.
- Develops procedures, trains other associates, and assists other technical associates.
- Hands-on involvement with all phases of his/her projects.
- Works effectively in team situations as well as independently.
- Performs other related duties as assigned or required based on education, knowledge, and previous experience.
**REQUIREMENTS**
- Requires a bachelor's degree in Engineering.
- Experience a minimum of 4-5 year's related experience.
- Experience In Medical Devices.
- Other Knowledge, Skills, Abilities or Certifications: Minimum 4years experience in the medical device or pharmaceutical industry.
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
- Ability to write routine reports and correspondence.
- Ability to speak effectively before groups of customers or employees of organization.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
**BUT ABOVE ALL**:
- Insatiable Curiosity
- Continuously Seeks to Improve
- Creativity and Innovation
- Problem Solving skills
- Good Communication & Leadership skills
- A Team Player
- Mathematical and Analytical Abilities Plus Logical Thinking
- Attention to Detail
- Embraces Change
- Optimistic
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