Highlights
Responsibilities:Draft and maintain DHF content including user needs, system/design requirements, software requirement specifications, design inputs, traceability matrices, and risk. Support V&V activities including drafting, execution and creation of test cases, reports and other testing artifacts.
Numbers & Facts
| Location | Warsaw, IN |
| Industry | Management Consulting Services |
| Salary | $48.80–$53.46 Per Hour |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | https://www.iconma.com/ |
Description
Our client, a Medical Devices/Healthcare company, is looking for a Systems Design / Product Development Engineer for their Salt Lake City, UT/Remote location.
Responsibilities:
Requirements:
Why Should You Apply?
Responsibilities:
- Draft and maintain DHF content including user needs, system/design requirements, software requirement specifications, design inputs, traceability matrices, and risk
- documentation
- 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
- Bachelor's degree in Engineering or a related science field; Biomedical Engineering preferred
Why Should You Apply?
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
Benefits
401K, Employee Referral Program, Life Insurance
About Company
ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.
- Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
- Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
- Founded in 2000
- 2000+ Employees
The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.