Operations Engineer

Job Title: R&D Test Engineer Location: Greenwood Village, CO Type: Contract Work Model: Onsite Hours: M - F 1st Shift

As an R&D Test Engineering Contractor, you will be an integral part of the new product development process, mainly supporting the Enabling Technology and Arthroscopy teams. Within the new product development process, this role will drive the functional evaluation of our products in the pre-market lifecycle, ultimately being responsible for the prototyping and development of electromechanical design verification test fixtures. This role will be part of the Test Engineering team, and will ensure the methods and equipment used in the verification of product design specifications are both effective and robust.

This role will leverage mechanical, electrical, and software skillsets to solve technical challenges in the prototyping of our test fixturing.

• Understand the intended use and functional specifications of a device
• Support testing activities for design decision making. Accountable for test strategy and execution and testing on a product from experimentation to design verification.
• Improve and/or develop new test methods using latest technology that are accurate, time-efficient, and cost effective. Critically assess and evaluate legacy test methods including hardware and documentation for use in future product pipeline. Be able to prioritize and optimize design decisions through this assessment and document traceability for old and new test fixturing.
• Design tests to fully measure requirements listed in the functional specifications, including automated test fixtures to execute tests. Test methods may include complex electromechanical fixturing which may require programming, electrical design, CAD, rapid prototyping, and fabrication.
• Verify fixtures and qualify test methods used for verification and validation
• Generate documentation for supporting verification and validation activities including test methods, test protocols, and test reports. Draw conclusions from test data.
• With guidance can effectively translate product requirements into test strategy and autonomously execute and proactively communicate the development work and progress made towards project goals. Can identify and elevate blockers and technical challenges to senior project team members as needed.
• Coordinate cross-functionally with Design, Regulatory, Quality Assurance, Advanced Manufacturing to integrate product specifications into fixture design.
• Potentially support Regulatory filing by providing technical input and responding to questions from Regulatory agencies.
• Apply understanding of clinical procedures to enhance product and patient outcomes.
• Communicate plans and technical information to broader team members, leaders, and project managers.
• Understand fundamental industry standards, design requirements and test strategies which align with regulatory requirements.
• Learn R&D procedures like design controls and risk management, per the Quality Management System.
• Work cooperatively with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success and contribute to the project as a team member.
• Learn procedures, policies, systems, and technology required.

• Bachelor’s degree (B.S.) in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or related curriculum
• Experience working in a regulated environment; knowledge of medical device quality systems, manufacturing, and design controls
• Knowledge of analysis tools and statistical methods
• Ability to analyze and correct complex designs.
• Foundational knowledge of software programming, electrical design, mechanical design (CAD & rapid prototyping)
• Strong technical writing skills for reports, protocols, procedures, and correspondence
• Python Scripting
• Electromagnetic fixture development
• Labview experience
• Hands-on mechanical and electrical design skills (CAD, fixture/jig design, sensor integration, and motor/actuator control) combined with fabrication and assembly knowledge (machining, wiring, pneumatics/hydraulics) and the test-engineering know-how to instrument, automate, and…