Job Description
Job Title: Systems Design / Product Development Engineer
Location: Salt Lake City, UT
Duration: 5 Months till year end 12/31/2026
Job Description
We're looking for a Systems Design / Product Development Engineer to support development of a software-based medical device (SaMD). The ideal candidate has a solid foundation in systems engineering and product development within a regulated environment, with hands-on experience drafting and maintaining design history file (DHF) content. This role plays a key part in refining and updating existing product documentation and ensuring continued regulatory alignment as the product moves through its lifecycle.
This role is open to remote candidates able to work Mountain Time hours, though candidates based onsite in Salt Lake City, UT are preferred.
Responsibilities
Requirements
Education
Bachelor's degree in Engineering or a related science field;Biomedical Engineering preferred.
Location: Salt Lake City, UT
Duration: 5 Months till year end 12/31/2026
Job Description
We're looking for a Systems Design / Product Development Engineer to support development of a software-based medical device (SaMD). The ideal candidate has a solid foundation in systems engineering and product development within a regulated environment, with hands-on experience drafting and maintaining design history file (DHF) content. This role plays a key part in refining and updating existing product documentation and ensuring continued regulatory alignment as the product moves through its lifecycle.
This role is open to remote candidates able to work Mountain Time hours, though candidates based onsite in Salt Lake City, UT are preferred.
Responsibilities
- Draft and maintain DHF content including user needs, system/design requirements, design inputs, traceability matrices, and risk documentation
- Define clear, testable requirements and support traceability across the design history file
- Support risk analysis activities (e.G. FMEAs) and contribute to usability engineering activities
- Support V&V activities including drafting, execution and creation of test cases, reports and other testing artifacts
- Collaborate cross-functionally with R&D, QA, Clinical, and Regulatory to translate technical information across stakeholder groups
Requirements
- 5+ years of experience in systems design/product development within a multi-disciplinary organization
- Demonstrated experience with SaMD development and regulatory documentation
- Working knowledge of ISO 14971;familiarity with ISO62304 and IEC 62366 preferred
- Experience drafting DHF artifacts (user needs, requirements, traceability matrices, risk files)
- Experience in a regulated, compliance-driven environment (FDA/QMS)
- Strong analytical skills and sound technical judgment
- Excellent written and verbal communication skills, with ability to work effectively with internal and external collaborators
- Experience with Codebeamer, JIRA, or similar requirements/traceability tooling
Education
Bachelor's degree in Engineering or a related science field;Biomedical Engineering preferred.
Numbers & Facts
| Location | Salt Lake city, UT |
| Industry | Staffing/Employment Agencies |
| Salary | $55 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.
Skills
- Analysis Skillsunmatched
- Atlassian JIRAunmatched
- Biomedical Engineeringunmatched
- Clinical Practices/Protocolsunmatched
- Communication Skillsunmatched
- Cross-Functionalunmatched
- Documentationunmatched
- FDA (Food and Drug Administration)unmatched
- File Maintenanceunmatched
- ISO (International Organization for Standardization)unmatched
- International Electro-Technical Commission (IEC)unmatched
- Machine Toolunmatched
- Maintain Complianceunmatched
- Medical Equipmentunmatched
- Presentation/Verbal Skillsunmatched
- Product Designunmatched
- Product Developmentunmatched
- Product Documentationunmatched
- Product Engineeringunmatched
- Quality Assuranceunmatched
- Regulationsunmatched
- Requirements Managementunmatched
- Research & Development (R&D)unmatched
- Riskunmatched
- Risk Analysisunmatched
- Software Administrationunmatched
- Software Developmentunmatched
- Systems Engineeringunmatched
- Technical/Engineering Designunmatched
- Test Caseunmatched
- Test Plan/Scheduleunmatched
- Traceabilityunmatched
- Usability Engineeringunmatched
- Writing Skillsunmatched
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