About the Role:

• Hardware tests for laser ablation capital system
• Conducting formal verification tests and writing reports. 
• Open to candidates with computer science, mechanical engineering, and electrical engineering background
• Need familiarity with PLM tools, MS office, Defector Issue Tracking tools.
• Familiarity with with EE and ME benchtop equipment is needed.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Responsible for plans, schedules and equipment required for testing including tool/fixture/phantom design.
• Compiles data and defines changes required in test equipment, testing procedures, manufacturing processes, or new testing requirements.
• Frequent use and application of technical standards, principles, theories, concepts, and techniques.
• Responsible for verification and validation of new or changed products including generating plans, protocols and reports for testing performed.
• Create, develop and maintain test software
• Ensures test equipment is in good working order and calibrated, as necessary
• Coordinates and oversees the testing of equipment and product at outside test facilities.
• Sets up and develops test tracking, monitoring and data recording systems.
• Provides solutions to a variety of technical problems of moderate scope and complexity.
• Participate in all phases of product development as needed such as reviewing requirements, design, usability, risk assessment and defects.
• Design, implement and/or execute automated testing.
• Identify and implement process improvements.
• Participate in defect tracking and analysis.
• Troubleshoot, debug, maintain, and support existing products.
• Effectively communicate findings, problems and solutions to project teams and stakeholders.
• Collaborate and maintain excellent working relationships with team members and stakeholders.
• All activities must be performed in compliance with the Quality System.
• Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations
• All other duties as assigned

Education/Experience

• Minimum of a B.S. / B.A. degree in Engineering.
• 2 + years of relevant experience with a Bachelors’ degree
• 0+ years of relevant experience with a Master’s degree or higher

Qualifications;

• Knowledge of applicable AAMI, ISO, FDA, ASME, IEC, and EN standards
• Working knowledge of hardware design, development, root cause analysis and test practices.
• Oral and written communication skills.
• Ability to work in a team environment.
• Self-motivated with strong problem solving skills and the ability to work independently.
• Able to handle multiple tasks/projects and manage priorities.
• Excellent written and verbal communication skills, including the ability to communicate effectively with business and technical audiences
• Mechanical cycling of instruments
• Cleaning instruments in a semi-automated washer
• Sterilizing instruments using an autoclave

Desired Skill Sets:

• Experience with medical device testing and understanding of FDA Quality System Regulations (QSR)
• Able to handle multiple tasks/projects and manage priorities
• Experience with test automation including GUI, integration and stress testing and designing and implementing test automation frameworks.
• Ability to work in a fast paced, collaborative team environment. Experience with Agile and iterative development practices is a plus.
• Project management skills including planning, estimation, tracking and communication
• Self-motivated with strong problem-solving skills and the ability to work independently
• Machine shop experience.
• Knowledge of statistical methods.

Location: On-site in Lafayette, CO

Salary Range: $80K - $100K

The actual salary offered is dependent on various factors including, but not limited to, location, the candidate’s combination of job-related knowledge, qualifications, skills, education, training, and experience