Jobs in the United States

25+ jobs

Save this search

Added 3 mins ago
M
Senior Software Engineer
Microsoft
WA · Redmond, WA · Redmond
- $119,800 to $261,000 USD / year
We are seeking a highly skilled and committed Senior Software Engineer to join our team. This role is central to advancing our quantum software roadmap and requires passion for software…
Added 3 mins ago
M
Principal Software Engineer
Microsoft
WA · Redmond, WA · Redmond
- $165,600 to $331,200 USD / year
We are hiring a Principal Software Development Engineer to join the Azure PostgreSQL team, where you will work on and drive innovations in one or more areas of a relational database…
Added 3 mins ago
M
Senior Software Engineering Manager
Microsoft
WA · Redmond, WA · Redmond
- $119,800 to $261,000 USD / year
…Redmond, WA, and at the Microsoft New England Research and Development Center, in Cambridge, MA, the Microsoft AI Development Acceleration Program (MAIDAP), which is part of the Office of…
Added 3 mins ago
M
Senior Mechanical Engineer
Microsoft
NC · Charlotte, NC · Charlotte
- $119,800 to $261,000 USD / year
…that powers our cloud services. As a CO+I Senior Mechanical Engineer, you will perform a key role in delivering the core infrastructure and foundational technologies for Microsoft's online…
Added 4 mins ago
M
Principal Software Engineer - AI Infrastructure
Microsoft
WA · Redmond, WA · Redmond
- $142,800 to $304,200 USD / year
As a Principal Software Engineer on this team, you will own the architecture and technical direction of major components of the training platform and drive them from ambiguous problem…
Added 4 mins ago
Electronic Ground Support Equipment (EGSE) Engineer - Level 3/4 (AHT)
SP - Orbital Space Systems
United States
…Early on, there will be design work that requires documentation development in not only electrical design, but also some mechanical design, then support to an EDL (Engineering Development…
Added 4 mins ago
M
Senior Cloud Network Engineer
Microsoft
United States
- $119,800 to $261,000 USD / year
As a Senior Cloud Network Engineer in the Azure Dedicated Team, you will design and operate Network Fabrics for both traditional ethernet networks and back-end networks such as RDMA and…
Added 12 mins ago
Integration Services Senior Engineer
Leidos
Pearl Harbor, HI
We are seeking a highly motivated and experienced Senior Network Engineer onsite at Ford Islan, Hawaii. In this Integration Services role, you will lead a team of engineers, perform project…
Added 24 mins ago
RI
Principal Turbomachinery Engineer
Radiant Industries
El Segundo, CA
- $200,500 to $314,475 USD / year
Radiant is seeking a Principal Turbomachinery Engineer to serve as the Responsible Engineer for the turbomachinery within our nuclear-driven power generation system. This role owns the…
Added 25 mins ago
T Developer/Engineer
Xinnovit
San Diego, CA
…full release cycles. Advanced understanding of modern software development methodologies. Advanced understanding of modern software developmenttools and SCM. Advanced understanding of…
Added 25 mins ago
Windows Server Engineer
Xinnovit
Olympia, WA
Test Manager MD)• To provide a return on investment to shareholders.
Added 25 mins ago
Oracle Software Engineer
Xinnovit
Charlotte, NC
A candidate must have experience in understanding/documenting requirements, design, development, test, documentation and defect resolution for software systems using Oracle databases.…
Added 25 mins ago
Senior Programmer
Xinnovit
Rancho Cordova, CA
…on the most complex IT applications design, documentation, development, modification, testing, installation, implementation and support of new or existing applications software. This…
Added 25 mins ago
Oracle Database Engineer
Xinnovit
Charlotte, NC
Client is looking for an experienced Oracle database software engineer to join the development team in Charlotte, North Carolina.
Added 25 mins ago
Performance Test Engineer (XIN001_JZB9)
Xinnovit
Foster City, CA
Strong Load script development in Citrix, HTTP, SOAP, Performance metrics data collection and analysis.
Added 25 mins ago
Build & Release Engineer(multiple locations)
US Tech Solutions
Chicago, IL
At least 2 years of experience in Architecture, Design, Development and Implementation of Continuous Integration (CI), Continuous Delivery (CD), Release Management, DevOps. Agile Project…
Added 25 mins ago
Software Engineer III
US Tech Solutions
Monroeville, PA
Technical writing, including development of test reports.
Added 25 mins ago
Senior Software Engineer
Zenith Talent Corporation
Boston, MA
Unit test development experience and having worked on agile projects are important as well.
Added 25 mins ago
Senior embedded software engineer
US Tech Solutions
Cary, NC
Develop test plans, then test the implemented code through unit tests and integration tests
Added 25 mins ago
Software QA Engineer - IoT
Xoriant
Denver, CO
As a QA Engineer, you will be responsible for architecting test plans, designing test cases, and providing hands on leadership during execution. The Engineering team utilizes a highly…
Added 25 mins ago
Engineer Degreed I
US Tech Solutions
Santa Clara, CA
4. Work with Martin in research algorithms for optimize and test algorithm performance for PLT and MCV Algorithms development in statistics, and/or signal/image processing and/or image…
Added 25 mins ago
Java/Cloud engineer
Xoriant
San Ramon, CA
Embraces technology trends that drive excellence beyond traditional practices (e.g., Test automation in lieu of traditional QA practices).
Added 25 mins ago
XT
Advanced Quality Engineer
Xyant Technology, Inc.
Litchfield, MI
- $75,000 to $80,000 USD / year
Job Title: Advanced Quality Engineer (Advanced Product Quality Planning / APQP)
Added 25 mins ago
Network Test Engineer
US Tech Solutions
San Francisco, CA
…technologies that power all of Client’s services. As a Networking Test Engineer you make sure that massive and growing network is operating at its peak potential. You have hands-on…
Added 25 mins ago
SAS Admin
US Tech Solutions
Tampa, FL
Under general supervision, the Associate Software Engineer reviews business requirements and information requests, existing programs, and file structures to complete the specified changes.…

Katalyst Healthcares & Life Sciences

Validation Engineer/CSV Engineer

Walnut Creek, CA, United States

Apply About employer

Applications open in a new tab.

Job details

Experience: Minimum of 4-5 years of experience in software quality assurance or software validation, preferably within the medical device industry.
Posting language: English
Posted: Jul 25, 2025

Original job description

Company Description

Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description

Job Description:

Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development.
Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software.
Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards.
Ensure computerized systems are appropriately validated Assessment of applicability & criticality of GxP and 21 CFR Part 11.
Creation and review of validation deliverables including but not limited to.

Responsibilities:

Requirement Specifications (User, Functional).
Plan.
Qualification Protocol (Installation, Operational, Performance) Reports (Summary, Exception) of protocol execution.
Traceability Matrix.
Periodic Reviews.
System Retirement/Decommissioning.
Execution of Dry/Test protocol run.
Conduct Periodic Reviews to determine if system is in a validated state and take appropriate actions.
Perform System Retirement/Decommissioning of systems not in business .
Work closely with software development and IT teams to establish best practices for quality and compliance.
Provide expertise and guidance on quality assurance processes for non-product software to ensure robust software management.
Drive continuous improvement initiatives in software development processes, ensuring alignment with the company's quality management system.

Requirements:

A Minimum bachelor's degree in engineering, Science or related technical field.
Minimum of 4-5 years of experience in software quality assurance or software validation, preferably within the medical device industry.
Strong understanding of quality standards and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
Experience with non-product software validation, including tools for development, testing, and maintenance.
Good knowledge and experience of CSV activities but not limited to.
GxP and 21 CFR Part 11 applicability/criticality assessment.
Identification, Preparation and Review of validation deliverables such as Requirements, Plan, Protocols, Test specifications, Reports, Traceability Matrix etc.
Execution of Dry/Test protocols.
Conduct Periodic Reviews of systems.
Perform System Retirement of systems that are not in business.
Understanding of Medical Device Quality and Compliance.
Good knowledge of GxP, GAMP and 21CFR Part 11 guidelines.
Working experience in Product Lifecycle Management (PLM) too.
sound knowledge of computer system development lifecycles.
Knowledge of JIRA, JAMA software and test automation is a plus. "
Computer System Validation, 21 CFR Part 11, GxP, FDA, 21 CFR Part 11, ISO 13485, IEC 62304.

Additional Information All your information will be kept confidential according to EEO guidelines.

Apply About employer

Report this job