Operations Engineer

System One; Greenwood Village (CO); On-site; USD 70,000 - 100,000; Part time

Job summary

System One is seeking an R&D Test Engineering Contractor in Greenwood Village, CO to drive functional evaluation, prototyping, and verification fixtures across Enabling Technology and Arthroscopy teams. This role combines mechanical, electrical, and software skills to instrument and validate test fixtures for long‑duration reliability.

You will design tests, automate fixtures, generate protocols, and collaborate with Design, Regulatory, QA, and Manufacturing to ensure compliance with design

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, Electrical or related field.
• Experience in a regulated environment and knowledge of medical device quality systems.
• Strong data analysis and statistical methods knowledge.
• Foundational knowledge of software programming and CAD/rapid prototyping.
• Strong technical writing skills for reports, protocols, and correspondence.
• Python scripting.
• Experience with electromagnetic fixture development and LabVIEW.
• Hands-on mechanical/electrical design and fabrication knowledge.
• Ability to operate small hand/tools and test equipment.

Responsibilities

• Understand device function and specifications.
• Support test strategy, execution, and design verification.
• Develop and improve test methods and fixtures using current technology.
• Design tests and automated fixtures to verify requirements.
• Verify fixtures and qualify test methods; document protocols and reports.
• Collaborate with cross‑functional teams to integrate product specs into fixtures.

Skills

Regulated environment

Quality systems

Data analysis

Design analysis

Programming basics

CAD

Technical writing

Python scripting

LabVIEW

Electrical design

Mechanical design

Hand tools

Sensor integration

Education

B.S. in Mechanical Eng

B.S. in Biomedical Eng

B.S. in Electrical Eng

Tools

LabVIEW

CAD

Electrical design

Rapid prototyping

Sensors integration

Job description

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

Position Summary

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.

Responsibilities

• 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.

Requirements

• 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 validate the fixture for long-duration reliability and life-cycle testing of products.
• Ability to operate small hand tools (e.g. pliers, screwdrivers, hammer, wrenches, etc.), power tools and test/inspection equipment

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.