Systems Designer
Spectraforce
Salt Lake City, Utah
Remote
3 hours ago
Job Description
Role: Systems Designer
Location: Remote or Salt Lake City, UT
Duration: 8+ months (possibility of extension)
This role is open to remote, as long as candidates are able to work Mountain Time hours, although the preference is onsite in Salt Lake City, UT.
Job Description:
The ideal candidate will have a solid background in system design and product development, with direct experience in regulatory compliance and documentation. You’ll play a key role in refining existing product documentation and ensuring continued regulatory alignment as part of an accelerated product remediation initiative.
Candidates must have experience with software as a medical device (SaMD) concepts.
Requirements
Education Requirements
Bachelor’s degree in engineering or science related field; biomedical engineering preferred.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 40.00/hr.
Location: Remote or Salt Lake City, UT
Duration: 8+ months (possibility of extension)
This role is open to remote, as long as candidates are able to work Mountain Time hours, although the preference is onsite in Salt Lake City, UT.
Job Description:
The ideal candidate will have a solid background in system design and product development, with direct experience in regulatory compliance and documentation. You’ll play a key role in refining existing product documentation and ensuring continued regulatory alignment as part of an accelerated product remediation initiative.
Candidates must have experience with software as a medical device (SaMD) concepts.
Requirements
- 5+ years of experience
- Strong experience in system design in a multi-disciplinary organization.
- Experience drafting and maintaining DHF (design history file) content, including user needs, system requirements, design inputs, traceability matrices, and risk documentation.
- Able to support risk analysis (e.g uFMEA etc) and contribute to usability planning and design mitigations.
- Familiarity with ISO 14971 is required, and IEC 62366 preferred.
- Ability to define testable requirements, support V&V protocol development, and ensure traceability in collaboration with the Product Development team.
- Strong collaboration skills across R&D, QA, clinical, and regulatory functions; able to clearly translate technical information across stakeholders.
- Must have experience in a regulatory environment with strict compliance.
- Strong analytical skills and accurate judgment making skills.
- Ability to deal effectively with internal and external collaborators.
- Excellent communications skills; written and verbal.
- Experience with Codebeamer and/or JIRA, or similar.
Education Requirements
Bachelor’s degree in engineering or science related field; biomedical engineering preferred.
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 40.00/hr.