Test Engineer I (Sterilization/Cleaning Validation experience/ Medical Device industry)

ENTEGEE, Inc.
Lafayette, CO, United States
28 days ago
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Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Starter
Experience required
0 years minimum
Compensation
$62,400.0 - $93,600.0
Working hours
Regular working hours
Job source

Tech stack

Data Analysis Verification and Validation (Software) Test Data

Job description

  • 2-3 years’ experience with Sterilization Validation / Microbiology is desirable. Cleaning Validation Experience generating technical documentation such as product requirements, specifications, engineering reports, test plans & procedures, validation plans, and/or validation reports The candidate will work in a fast pace environment and is expected to have optimal critical thinking skills and a collaborative mindset to succeed in this role. The candidate is expected to have hands on EO validation sterilization experience and a working knowledge of ISO 11135:2014, ISO 10993-7:2008/AMD 1: 2019, and ISO 11737 series. Most importantly, the candidate must be a technical leader, able to handle a project with little to no oversight., Responsibilities may include the following and other duties may be assigned. Designs, develops, and implements testing methods and equipment. Plans and arranges the labor, schedules, and equipment required for testing and evaluating standard and special devices. Provides test area with parameters for sample testing and specifies tests to be performed. Compiles data and defines changes required in testing equipment, testing procedures, manufacturing processes, or new testing requirements. Responsible for testing all customer samples and for special tests that cannot be performed in the test area.

Requirements

  • 0-2 years of experience with testing and data analysis, creating test protocols and reports., * Verification and Validation Protocol and Report Execution and Documentation: Translating requirements into repeatable test protocols, executing testing, documenting results, and understanding concepts like sample-size, TMV, and acceptance criteria.
  • Technical Problem Solving - Experience analyzing test data, troubleshooting failures, and determining root cause.
  • Reprocessing and Sterilization Testing: Ability to safely execute reprocessing involving autoclave sterilization and assess the impact of processing on product performance.

Education: Bachelors in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Manufacturing Engineering, or another related engineering/technical discipline.

Years Experience: 0-2 Years of relevant experience

Benefits & conditions

(part of The Adecco Group) 3.73.7 out of 5 stars Lafayette, CO 80026 Hybrid work $30 - $45 an hour - Full-time, Contract, Pulled from the full job description

  • 401(k)
  • Health insurance
  • Paid time off
  • Vision insurance
  • Dental insurance
  • Life insurance
  • Disability insurance, * 401(k)
  • Dental insurance
  • Health insurance
  • Paid time off
  • Vision insurance

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