Bachelor's or Master's degree in Mechanical, Biomedical, Electrical, or a related engineering field.
Experience in R&D; within the medical device industry, with direct involvement in product design and development.
Strong understanding of design controls per FDA requirements and relevant ISO and IEC/ISO standards related to the product type.
Proven ability to conduct engineering studies, testing, and technical evaluations in a regulated environment.
Demonstrated experience generating audit-ready documentation, including design inputs and outputs, risk analyses, and V&V; protocols and reports.
Excellent technical writing skills with the ability to produce clear, accurate, and compliant documentation.
Hands-on experience with risk management activities such as FMEA and fault-tree analysis for medical devices.
Ability to collaborate effectively with cross-functional teams including Regulatory Affairs, Quality Assurance, Clinical, and Manufacturing.
Strong problem-solving skills with the ability to investigate design issues and support CAPA activities.
Experience working with Class IIb or Class III medical devices.
Proficiency with SolidWorks for mechanical design and modeling.
Experience using Windchill or similar product lifecycle management (PLM) systems.
Familiarity with IEC standards for medical electrical equipment safety.
Background in mechanical engineering and medical device design.
Ability to contribute to project planning and schedule development in an R&D; environment.
This is a onsite role based in Denver, Colorado.
This is a Contract position based out of Centennial, CO.
