Test Engineer I

Planet Pharma; Lafayette (CO); On-site; USD 41,000 - 51,000; Full time

Job summary

Planet Pharma in Lafayette, Colorado, is seeking a skilled Technical Specialist to contribute to testing, development, and evaluation of regulated devices. The role focuses on applying established standards and advancing testing methods.

The ideal candidate brings a Bachelor’s degree and hands-on experience with software testing practices, with an emphasis on AI-assisted efficiency and thorough documentation.

Qualifications

• Knowledge of applicable AAMI, ISO, FDA and EN standards or relevant work experience in a regulated environment.
• Experience with software design, development, debugging and test practices.
• Experience utilizing AI tools to improve work efficiency, including writing and debugging test scripts, analyzing code or requirement changes, and streamlining documentation and reporting tasks

Responsibilities

• 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.

Skills

Regulatory standards

Software design

AI tools usage

Education

Bachelor's degree

Job description

Pay 30-37/h depending on experience

3 Technical Skills That Are Required For The Role

• Knowledge of applicable AAMI, ISO, FDA and EN standards or relevant work experience in a regulated environment
• Working knowledge of software design, development, debug and test practices.
• Experience utilizing AI tools to improve work efficiency, including writing and debugging test scripts, analyzing code or requirement changes, and streamlining documentation and reporting tasks

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.

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 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), 0 years of experience required.