Test Engineer I Exempt

Join our dynamic team in Lafayette CO a vibrant community nestled at the foothills of the Rocky Mountains. Embrace the opportunity to work in a fast-paced environment where innovation meets collaboration.

• 0-2 years of experience with testing and data analysis creating test protocols and reports.
• 2-3 years experience with Sterilization Validation/Microbiology is desirable.
• Experience in Cleaning Validation.
• Experience generating technical documentation such as product requirements specifications engineering reports test plans & procedures validation plans and/or validation reports.
• 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.
• Technical leadership skills to handle projects with little to no oversight.

• 3D CAD Modeling

• 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.

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

0-2 Years of relevant experience

40 hours/week onsite required 4x per week.

Responsibilities may include the following and other duties may be assigned:

• Design develop and implement testing methods and equipment.
• Plan and arrange the labor schedules and equipment required for testing and evaluating standard and special devices.
• Provide test area with parameters for sample testing and specify tests to be performed.
• Compile data and define 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.

An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering R&D systems or initiatives related to new technologies or therapiesfrom design to implementationwhile adhering to policies using specialized knowledge and skills.

• Autonomy: Entry-level individual contributor on a project or work team. Works with close supervision.
• Organizational Impact: Delivers work of limited scope typically smaller less complex projects or related activities.
• Innovation and Complexity: Identifies defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems.
• Communication and Influence: Communicates primarily with internal contacts within the immediate group. Contacts others to gather confirm and convey information.
• Leadership and Talent Management: N/A job at this level is focused on self-development.

Requires broad theoretical job knowledge typically obtained through advanced education. Requires a Baccalaureate degree (or for degrees earned outside of the United States a degree which satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A)).