US_East | Product / System & PLM Engineer_L2
Expedite Technology Solutions LLCa day ago
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OnsiteFull-timeMid
Summary
Expedite Talent Solutions is seeking a Non-Product Software Validation Engineer to join their medical technology team in Plano, TX. The role involves ensuring compliance of non-product software systems with ISO 13485 standards and applicable regulatory requirements.
About the Role
As a Non-Product Software Validation Engineer, you will be responsible for planning, executing, and documenting validation activities for non-product software systems. Your tasks will include developing validation protocols, conducting gap analyses, creating validation documentation, collaborating with cross-functional teams, participating in audits, and supporting change control processes.
About You
Required:
- Bachelor's degree in Engineering, Computer Science, or related technical field.
- Minimum 5 years of experience in software validation within a regulated medical device environment.
- Demonstrated knowledge of ISO 13485 requirements for non-product software validation.
- Proficiency in risk management techniques (FMEA, FTA) as applied to software systems.
- Strong understanding of 21 CFR Part 11 compliance for electronic records/signatures.
- Excellent documentation and technical writing skills.
- Strong analytical and problem-solving abilities.
- Effective communication skills with the ability to explain technical concepts to non-technical stakeholders.
Preferred:
- Master's degree in related field.
- Knowledge of additional regulatory frameworks (FDA QSR, EU MDR, MDSAP).
- Background in computer system validation methodologies.
- Experience with validation of computerized systems in medical device environments.
- Familiarity with embedded software development lifecycles.
Expedite Technology Solutions LLC
Expedite Technology Solutions has an extensive background in technology outsourcing, professional services, and staffing. We offer the expertise of a global company combined with ‘one to one’ customized service of a local business partner. Whether you want an implementation specialist for a short-term project or a software developer to add to your team, Expedite will work with you to provide the top-notch IT professionals you need. We can help you identify the right technical resources and manage the hiring process, or provide you with a complete project solution.
Plano, TX