Top 3 required skills:-Prior experience in a medically regulated industry (Class II or III highly preferred)-Design verification and validation experience in the medical device industry-Exposure to failure mode analysis.-Test method validation-Design verification (plans & protocols), reporting, and testing-Data failure analysis on the design verification testing
Job Responsibilities:
- Test, and/or improve products by developing moderately complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles
- Generate work instructions, test methods, engineering drawings/prototypes, etc. to establish/characterize product and/or process specifications.
- Create/update portions of design control documents including requirement specs and risk documents.
- Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers.
Requirements:
- Good computer skills in usage of MS Office Suite; CAD experience preferred, not required
- Basic understanding of statistical techniques
- Previous experience working with lab/industrial equipment required (if applicable)
- Bachelor's degree in engineering required.
- 0-2 years experience required.
Job Type: Contract
Pay: $30.50 - $31.92 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Experience level:
Schedule:
Experience:
- medical devices: 2 years (Required)
- r&d: 2 years (Required)
- Test method validation: 2 years (Required)
- Design verification: 1 year (Required)
- medical device Class II or III: 1 year (Required)
- failure mode analysis: 1 year (Required)
Ability to Commute:
- Irvine, CA 92602 (Required)
Ability to Relocate:
- Irvine, CA 92602: Relocate before starting work (Required)
Work Location: In person