Systems Design Engineer

Lancesoft

Salt Lake city, UT

JOB DETAILS
SALARY
$55
SKILLS
Analysis Skills, Atlassian JIRA, Biomedical Engineering, Clinical Practices/Protocols, Communication Skills, Cross-Functional, Documentation, FDA (Food and Drug Administration), File Maintenance, ISO (International Organization for Standardization), International Electro-Technical Commission (IEC), Machine Tool, Maintain Compliance, Medical Equipment, Presentation/Verbal Skills, Product Design, Product Development, Product Documentation, Product Engineering, Quality Assurance, Regulations, Requirements Management, Research & Development (R&D), Risk, Risk Analysis, Software Administration, Software Development, Systems Engineering, Technical/Engineering Design, Test Case, Test Plan/Schedule, Traceability, Usability Engineering, Writing Skills
LOCATION
Salt Lake city, UT
POSTED
1 day ago
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
  • 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.

About the Company

L

Lancesoft

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.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2000
WEBSITE
http://www.lancesoft.com/