Description
AppleOne is proud to present:
Systems Designer – Medical Device (SaMD)
Salt Lake City, UT (Preferred)
Remote – Mountain Time
Regulated Medical Device Environment
About the Role
We are seeking an experienced Systems Designer with a strong background in medical device systems design, SaMD concepts, regulatory compliance, and DHF documentation. You will support a fast-paced product remediation initiative, ensuring documentation accuracy, regulatory alignment, and quality excellence.
You will work cross-functionally with R&D, QA, Clinical, and Regulatory teams while contributing to risk analysis, usability considerations, and V&V readiness.
Key Responsibilities
Develop and refine system design documentation within DHF
Maintain user needs, requirements, design inputs, and traceability matrices
Support risk management including uFMEA / ISO 14971 practices
Contribute to usability planning & mitigations (IEC 62366 preferred)
Define testable requirements and support V&V documentation & protocols
Ensure regulatory compliance throughout development lifecycle
Collaborate across engineering, QA, clinical, and regulatory teams
Ensure clarity, structure, and regulatory rigor in documentation
Utilize platforms such as Codebeamer, JIRA, or similar tools
Requirements
5+ years experience in system design within regulated environments
Strong background in SaMD (Software as a Medical Device)
Hands-on experience drafting and maintaining DHF content
Experience supporting risk analysis and usability engineering
Familiarity with ISO 14971 (Required)
Experience with IEC 62366 (Preferred)
Demonstrated experience working in strict compliance environments
Excellent communication, collaboration, and analytical skills
Experience with Codebeamer / JIRA / Similar lifecycle tools
Education
Bachelor’s degree in Engineering or Science
Equal Opportunity Employer / Disabled / Protected Veterans
The Know Your Rights poster is available here:
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf
The pay transparency policy is available here:
https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf
For temporary assignments lasting 13 weeks or longer, the Company is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.
We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.
AppleOne participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.
https://e-verify.uscis.gov/web/media/resourcesContents/E-Verify_Participation_Poster_ES.pdf
We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
#8820
Experienced (Non-Manager)