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Technical Writer - Life Science
Job Number: 347583
Category: Design
Description: Job Title: Engineer
Pay Rate: $41.06 / hr.
Location: Thousand Oaks, CA
ZIP Code: 91320
Start Date: Right Away
Keywords: #Engineering
Job Description:
This position reports into the Combination Product Operations Development and Lifecyle Management group in Thousand Oaks, CA, supporting senior staff in design, characterization, and qualification of combination products. This position requires the application of engineering principles to perform the job functions and the ability to coordinate and communicate effectively across different functions to successfully complete projects.
This role will be required to:
Plan and author technical documentation, including test plans/protocols/reports and a variety of engineering assessments.
Perform hands on testing of autoinjector devices, including the safe operation of test equipment and devices containing sharps (syringes).
Analyze and report data, along with any recommendations, to a variety of stakeholders.
Provide technical input for mechanical problems to programs as needed.
Plan and execute tolerance and robustness analysis of complex mechanical designs.
Use project planning and monitoring methods to ensure accurate completion.
Collaborate with cross-functional teams to ensure adequate sustainment and improvement of products throughout their lifecycle.
As part of the team working on device platforms, ensure alignment to architecture to support variations of the platform and system deliverable packages.
Basic Qualifications
B.S. in Engineering or Scientific Discipline
Effective Communicator (Oral/Written)
Technical Writing (Protocols, Reports, Technical Assessments, Presentations)
Preferred/Demonstrated Competencies
Broad set of knowledge and expertise in contributing to complex, multi-disciplinary and cross-functional product development efforts
Experience in drug/device combination product design, and development
Background in development, commercialization, and lifecycle management of medical devices
Physical test method development, qualification, and validation
Experience executing lab tests, including safe and proper operation of lab equipment (Instron tensile tester, Keyence inspection equipment, etc.)
Experience conceptualizing, designing, and building test fixtures
Technical understanding of drawings including tolerance stacks and robustness analysis
Knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position
Familiarity with the following standards: US Good Manufacturing Practices (21CFR820), Quality Management (ISO 13485), Risk Management (ISO 14971), EU Medical Device requirements (Council Directive 93/42/EEC), Needle Based Injection Systems (EN ISO 11608-1), and Medical Electrical Equipment (EN 60601)
Knowledge of dFMEA/pFMEA
Capable of working on multiple projects in a deadline driven environment
Strong oral and written communication skills, decision making, presentation, and organization skills
Ability to collaborate and converse technically with diverse partners such as hardware, software, systems, human factors, materials science, quality, reliability engineering, domain experts from commercial, clinical, molecular research, medical sciences, regulatory, drug substance and drug product development organizations
Demonstrate ability to navigate ambiguity and provide a structured problem-solving approach
Track record of building or participating as a member of successful teams
Working knowledge of MS Office tools
If you are interested in this role, please apply via the apply now link provided. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract, temporary, temp-to-hire, and direct assignments. We are the employer of choice for thousands worldwide. For more information, please visit our website at Belcan.com
EOE/F/M/D/V
Location: Thousand Oaks , CA
Minimum Experience (yrs):
Required Education: Not Specified
Benefits:
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