Utah Staffing
Systems Designer-SaMD
IDR is seeking a Systems Designer-SaMD to join one of our top clients in Salt Lake City, Utah. This role is pivotal in supporting the migration of systems and requires expertise in Software as a Medical Device (SaMD) concepts. If you are looking for an opportunity to join a growing organization and work within an ever-growing team-oriented culture, please apply today! Position Overview/Responsibilities for the Systems Designer-SaMD: Collaborate with our clients team to design and maintain Design History File (DHF) content, including user needs and system requirements. Support risk analysis and contribute to usability planning and design mitigations. Define testable requirements and support the development of verification and validation protocols. Work closely with R and D, QA, clinical, and regulatory teams to ensure compliance and effective communication. Required Skills for Systems Designer-SaMD: Minimum of 5 years of experience in system design within a multi-disciplinary organization. Proficiency in drafting and maintaining DHF content and familiarity with ISO 14971; IEC 62366 is preferred. Strong analytical skills and experience in a regulatory environment with strict compliance. Experience with tools like Codebeamer and/or JIRA. Bachelor's degree in engineering or a science-related field, with a preference for biomedical engineering. What's in it for you? Competitive compensation package Full benefits; medical, vision, dental, and more! Opportunity to get in with an industry leading organization Close-knit and team-oriented culture Why IDR? 25+ years of proven industry experience in 4 major markets Employee Stock Ownership Program Dedicated engagement manager who is committed to you and your success Medical, dental, vision, and life insurance Clearly Rated's Best of Staffing Client and Talent Award winner 12 years in a row All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. IDR is subject to certain governmental recordkeeping and reporting requirements for the administration of civil rights laws and regulations. In order to comply with these laws, we invite employees to voluntarily self-identify their race or ethnicity, gender, and veteran status (if applicable). Submission of this information is voluntary and refusal to provide it will not subject you to any adverse treatment. The information obtained will be kept confidential and may only be used in accordance with the provisions of applicable laws, executive orders, and regulations, including those that require the information to be summarized and reported to the federal government for civil rights enforcement.
IDR is seeking a Systems Designer-SaMD to join one of our top clients in Salt Lake City, Utah. This role is pivotal in supporting the migration of systems and requires expertise in Software as a Medical Device (SaMD) concepts. If you are looking for an opportunity to join a growing organization and work within an ever-growing team-oriented culture, please apply today! Position Overview/Responsibilities for the Systems Designer-SaMD: Collaborate with our clients team to design and maintain Design History File (DHF) content, including user needs and system requirements. Support risk analysis and contribute to usability planning and design mitigations. Define testable requirements and support the development of verification and validation protocols. Work closely with R and D, QA, clinical, and regulatory teams to ensure compliance and effective communication. Required Skills for Systems Designer-SaMD: Minimum of 5 years of experience in system design within a multi-disciplinary organization. Proficiency in drafting and maintaining DHF content and familiarity with ISO 14971; IEC 62366 is preferred. Strong analytical skills and experience in a regulatory environment with strict compliance. Experience with tools like Codebeamer and/or JIRA. Bachelor's degree in engineering or a science-related field, with a preference for biomedical engineering. What's in it for you? Competitive compensation package Full benefits; medical, vision, dental, and more! Opportunity to get in with an industry leading organization Close-knit and team-oriented culture Why IDR? 25+ years of proven industry experience in 4 major markets Employee Stock Ownership Program Dedicated engagement manager who is committed to you and your success Medical, dental, vision, and life insurance Clearly Rated's Best of Staffing Client and Talent Award winner 12 years in a row All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. IDR is subject to certain governmental recordkeeping and reporting requirements for the administration of civil rights laws and regulations. In order to comply with these laws, we invite employees to voluntarily self-identify their race or ethnicity, gender, and veteran status (if applicable). Submission of this information is voluntary and refusal to provide it will not subject you to any adverse treatment. The information obtained will be kept confidential and may only be used in accordance with the provisions of applicable laws, executive orders, and regulations, including those that require the information to be summarized and reported to the federal government for civil rights enforcement.