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.

Must Have:

• 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.

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:

Bachelor's in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Manufacturing Engineering, or another related engineering/technical discipline.

Years of Experience:

0-2 Years of relevant experience

Work Schedule:

40 hours/week, onsite required 4x per week.

Responsibilities:

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.

Technical Specialist Career Stream:

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 therapies—from design to implementation—while adhering to policies, using specialized knowledge and skills.

Differentiating Factors:

• 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.

Required Knowledge and Experience:

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)).