Katalyst CRO ยท 3 months ago
Software Verification Engineer
Katalyst Healthcares & Life Sciences is seeking a Software Verification Engineer with extensive experience in medical device verification and validation. The role involves writing and executing verification protocols and reports for embedded medical devices, ensuring compliance with FDA regulations and industry standards.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
5+ Years' experience in medical device V&V for a large company
Experience with FDA-regulated V&V
IEC 62304 experience
Meaningful direct experience in writing verification protocols, executing protocols, and reports for embedded class 2+ medical devices
Basic electrical and electronic communication skills
Complete understanding of GDP
Fluent in technical English
Able to attend virtual meetings during US Central Time
Agile experience (plus)
Cybersecurity verification experience (plus)
Must have Medical Device domain experience
Customer is looking specifically for embedded device expert , makes sure candidate has experience in Embedded/Firmware
Qualification
Required
5+ Years' experience in medical device V&V for a large company
Experience with FDA-regulated V&V
IEC 62304 experience
Meaningful direct experience in writing verification protocols, executing protocols, and reports for embedded class 2+ medical devices
Basic electrical and electronic communication skills
Complete understanding of GDP
Fluent in technical English
Able to attend virtual meetings during US Central Time
Must have Medical Device domain experience
Customer is looking specifically for embedded device expert, makes sure candidate has experience in Embedded/Firmware
Preferred
Agile experience (plus)
Cybersecurity verification experience (plus)
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageRecent News
2024-04-07
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