Test Engineer - Exempt

Job Opportunity in Lafayette, CO

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.

Bachelor's 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 therapies—from design to implementation—while 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)).