Manufacturing Engineer

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.




Location: This role is an in-office role based in Denver, Colorado working out of the client office in Greenwood Village, CO. In office 5 days per week.
Hours: Full time role, 40 hours per week.
Duration: 12-18 month contract.




Technical 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.
A preferred candidate brings 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.
Business Responsibilities:
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 escalate 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.




Med Device Compliance
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.




General Responsibilities
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, processes, systems, and technology required.




EDUCATION REQUIREMENTS
Bachelor's degree (B.S.) in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or related curriculum
Must be able to read, write, and speak fluently in English about technical subject matter




Technical Skills
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.
Excellent analytical and problem-solving skills.
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




Physical:
Ability to operate small hand tools (e.g. pliers, screwdrivers, hammer, wrenches, etc.), power tools and test/inspection equipment
Exerting up to 30 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, etc.
Must have the ability to work with and assemble small objects and component parts
Must have good visual acuity and demonstrate fine motor skills
Must be able to observe and correct minute inconsistencies (e.g. in the printed word, product appearance, etc.)