Systems Design / Product Development Engineer
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Overview
Remote
On-site
Compensation
$49-$53/hour
Job 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:
- 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
- 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
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
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FAQs About Systems Design / Product Development Engineer Jobs at ICONMA, LLC
What is the work location for this position at ICONMA, LLC?
This job at ICONMA, LLC is located in Warsaw, IN, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at ICONMA, LLC?
Candidates can expect a pay range of $48.8–$53.46 per hour for this role.
What employment applies to this position at ICONMA, LLC?
The employer has not provided this information. This may be discussed during the hiring process.
What is the process to apply for this position at ICONMA, LLC?
You can apply for this role at ICONMA, LLC either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.