Validation Engineer I

Test Engineer I

Primary Talent Partners has a new contract opening for a Test Engineer I with our medical device client in Lafayette, CO. This is an 11-month contract with a potential for extension.

Pay: $34.00 - $44.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment. Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship.

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.

Must Have:

• 1-2 years of experiences with testing and data analysis, creating test protocols and reports
• 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.

Nice to Have:

• 3D Cad Modeling

Top 3 skills:

• 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: 1-2 Years of relevant experience

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws. If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at View email address on click.appcast.io