Software Verification Engineer jobs in United States
cer-icon
Apply on Employer Site
company-logo

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
check
Comp. & Benefits
check
H1B Sponsor Likelynote

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

Medical Device V&VFDA-regulated V&VIEC 62304Embedded Device ExpertiseCybersecurity VerificationAgile ExperienceBasic Electrical SkillsGDPTechnical English

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

twittertwittertwitter
company-logo
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 Stage

Leadership Team

leader-logo
John Patil
Recruiter, Pharma/CRO Staffing Division
linkedin
Company data provided by crunchbase