Our client, one of the world's largest and most prestigious healthcare product organizations, is looking for experienced R&D/Design Engineer who is comfortable working in a fast-paced environment, and working on mutiple projects & design concepts simultaneously for their Orange County, CA campus. The individual will have 5+ years of project/project management responsibilities across multiple product platforms, including ENT, electrophysiology, neurology, vision, and surgical & non-surgical aesthetics. They will provide engineering & design services to the R&D team, and develop concepts, designs & details for products, machines, tools, fixtures and test methods. Bachelor's Degree in Mechanical or Biomedical Engineering required (will consider other relevant disciplines), advanced degree strongly preferred.
location: Irvine, California
job type: Permanent
salary: $135,000 - 145,000 per year
work hours: 8am to 4pm
education: Bachelors
responsibilities:
- Designs new devices based upon customer need
- Tests design prototypes and modifies design based upon test results
- Documents design for V&V activities
- Plans, coordinates and oversees validation operations, including scale up of and optimization processes, equipment assembly, in process sample analysis, and prepares compliance documents
- Proposes and determines new or improved technologies to enhance product quality, manufacturing cost efficiencies, personnel safety and regulatory compliance
- Evaluates analytical results to establish the quality of batches
- Prepares and controls procedure, batch records and other compliance documents
- Oversees timely completion of pilot plant operations consistent with new product production activities of the department
- Manages the transfer of manufacturing technologies from concept to pilot scale
- Prepares and assists in the execution of the manufacture of process validation batches, and prepares the process validation report
- Ensures equipment is tested and supports safety and environmental initiatives
- Ensures repairs are scheduled
- Creates IP and works with patent attorneys to ensure patents are applied for
qualifications:
- Experience level: Experienced
- Minimum 5 years of experience
- Education: Bachelors (required)
skills:
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Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
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