Overview
On Site
$50
Contract - W2
Contract - 2 day((s))
Skills
Validation
Software
Verification
Job Details
Job Summary for Sr. Instrument Verification and Validation Engineer
- Lead formal verification and validation (V&V) activities for complex medical devices in compliance with FDA regulations.
- Design and implement software for embedded devices and systems, including developing, coding, testing, and debugging system software.
- Develop and execute requirements-based manual test cases and procedures in a BL2 lab environment.
- Analyze test results, document findings, and manage system software defects.
- Assess system requirements for testability and determine optimal test approaches.
- Participate in collaborative team meetings, formal reviews, and test planning activities.
- Work closely with software development teams and partners to reproduce and verify system defects.
- Support project goals and timelines to ensure successful product launch.
- Engage in off-hour meetings with international partners (e.g., China).
- Ensure compliance with relevant standards (IEC 62304, ISO 13485, ISO 14971, FDA QSR).
- Apply experience in product development, experimental design, and quality systems regulations.
- Utilize configuration management, defect tracking, and peer review tools.
- Prepare test plans, test cases, and test reports.
- Manage multiple tasks and work within cross-functional teams.
- Maintain professionalism, strong communication skills, and a proactive, self-motivated work ethic.
- 100% onsite work at Rochester, NY location with up to 20% travel (airplane, car, overnight stays).
- Willingness to work overtime and attend early/late meetings as required.
- Lead formal verification and validation (V&V) activities for complex medical devices in compliance with FDA regulations.
- Design and implement software for embedded devices and systems, including developing, coding, testing, and debugging system software.
- Develop and execute requirements-based manual test cases and procedures in a BL2 lab environment.
- Analyze test results, document findings, and manage system software defects.
- Assess system requirements for testability and determine optimal test approaches.
- Participate in collaborative team meetings, formal reviews, and test planning activities.
- Work closely with software development teams and partners to reproduce and verify system defects.
- Support project goals and timelines to ensure successful product launch.
- Engage in off-hour meetings with international partners (e.g., China).
- Ensure compliance with relevant standards (IEC 62304, ISO 13485, ISO 14971, FDA QSR).
- Apply experience in product development, experimental design, and quality systems regulations.
- Utilize configuration management, defect tracking, and peer review tools.
- Prepare test plans, test cases, and test reports.
- Manage multiple tasks and work within cross-functional teams.
- Maintain professionalism, strong communication skills, and a proactive, self-motivated work ethic.
- 100% onsite work at Rochester, NY location with up to 20% travel (airplane, car, overnight stays).
- Willingness to work overtime and attend early/late meetings as required.
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