fda jobs

San Jose, California

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3d ago

Job Description: Role : Validation Engineer Location : San Jose, CA (On-site)/Local only Primary Focus: Simulator Development (C#), Automation (Squish), & Firmware/Hardware Validation In this pivotal role, you will own the enhancement and maintenance of our proprietary Software Simulator the critical tool used to validate our robotic surgical hardware and firmware without needing the physical robot every time. You will spend the majority of your time coding in C# to expand the simulator's capab

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Contract

Depends on Experience

Automation Engineer (Medical Device Exp must)

Pleasanton, California

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9d ago

Key Responsibilities: Design and develop automation frameworks using TypeScript, JavaScript, Node.js.Implement UI automation using Playwright and Cypress.Build and maintain API automation solutions.Integrate automation suites with test management tools.Collaborate with developers and QA teams to ensure BDD practices using Cucumber.Set up and maintain CI/CD pipelines for automated test execution.Participate in code reviews and contribute to best practices for test automation.Troubleshoot and opti

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Contract

Up to $65

Technical Writer

Hybrid in Minneapolis, Minnesota

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25d ago

Description: Hybrid Role - 3 day in and 2 remote. Locations would be Colorado Springs or Plymouth, MN (preferred). In this role, you have the opportunity to Bring your passion and energy into a growing department dedicated to the quality output of product labeling and packaging for Image Guided Therapy (IGT) devices in accordance with GMP s, FDA Regulations, EUMDR, ISO Requirements and Standard Company Operating Procedures. You are responsible for Develop and maintain Instruction For Use (IFUs)

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Full-time

$50+

Sr Level CSV Engineer

North Carolina

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Today

Title: Sr. Level CSV Engineer Location: NC Exp: At least 8-12yrs THIS IS A BACKFILL Client is seeking an experienced CSV Engineer to support key validation activities at a leading pharmaceutical manufacturing site. The contractor will play a critical role in ensuring compliance with regulatory and company standards by providing validation and technical support throughout the lifecycle of various systems and processes. Qualifications: Degree: Bachelor's degree in Engineering, Computer Science

Third Party, Contract

Cloud Engineer

Waukesha, Wisconsin

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11d ago

Key Responsibilities Design and implement cloud-based pipelines for ingesting, storing, and processing DICOM imaging data from edge devices.Develop and maintain backend services and APIs using modern frameworks (e.g., Python, Java).Integrate with DICOMWeb services, including STOW-RS, WADO-RS, and QIDO-RS, for image upload, retrieval, and query.Automate infrastructure provisioning using Infrastructure-as-Code tools (e.g., AWS CDK, Terraform).Ensure secure data transmission using TLS, IAM, and OAu

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Contract, Third Party

$70 - $80

Simulation Engineer

San Jose, California

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16d ago

Job Title: Simulation Engineer Location:San Jose, CA (On-site) Duration: long term contract Primary Focus:Simulator Development (C#), Automation (Squish), & Firmware/Hardware Validation In this pivotal role, you will own the enhancement and maintenance of our proprietary Software Simulatorthe critical tool used to validate our robotic surgical hardware and firmware without needing the physical robot every time. You will spend the majority of your time coding in C#to expand the simulator's capa

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Third Party, Contract

Depends on Experience

Epic - Business Intelligence Developer I, II, III (100% Onsite)

Whittier, California

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Today

The Business Intelligence Developer create analytics content for end users and third parties who require Epic data. The Business Intelligence Developer is critical in transforming healthcare data into actionable insights through the development of dashboards, reports, and analytics solutions using Epic's reporting tools. The ideal candidate will have hands-on experience with Caboodle, and related tools, along with a strong understanding of healthcare operations and clinical workflows. PIH Health

Full-time

USD 92,955.20 - 169,104.00 per year

Controls Engineer

North Haven, Connecticut

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5d ago

Develop, modify, and optimize Rockwell Automation (Allen-Bradley) PLC and Motion Control programs for automated equipment. Design, integrate, and troubleshoot vision inspection systems (Cognex/Keyence) to ensure robust defect detection and in-line quality verification. Lead controls architecture reviews, safety evaluations, and equipment readiness assessments for new and existing lines. Execute IQ/OQ/PQ protocols, ensuring alignment with FDA, ISO 13485, and internal QMS requirements. Partner

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Full-time

Depends on Experience

Regulatory Affairs Specialist Consultant

Newton, Massachusetts

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Today

Location: Newton, MA Salary: $65.00 USD Hourly - $87.00 USD Hourly Description: Our client is currently seeking a Regulatory Affairs Specialist Consultant for a 12 month + contract. As a Regulatory Affairs Specialist Consultant you will be responsible for: Formulate and execute activities associated with regulatory submissions of a novel robotic medical device in the US market as well as markets outside of the US (e.g. Europe, Asia). In collaboration with subject matter experts, independen

Contract

USD 65.00 - 87.00 per hour

Project (Design) Mgr 3

Sunnyvale, California

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7d ago

Position Summary: We are seeking a dynamic and experienced Software Project Manager to lead and coordinate the development of cutting-edge surgical robotic platforms. The successful candidate will be responsible for managing software development lifecycles, ensuring timely delivery, compliance with medical device standards, and collaboration across multidisciplinary teams including but not limited to: product management, software & controls engineers, hardware engineers, clinical design enginee

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Contract

$75

Test Lead - Embedded Device Testing

Massachusetts

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Today

Develop and execute verification and validation plans, protocols, and test cases for software and hardware tools. Collaborate with cross-functional teams to define validation requirements. Perform risk assessments and impact analyses for software changes. Document verification and validation results and maintain traceability matrices. Ensure compliance with relevant standards (e.g., FDA 21 CFR Part 11, ISO 13485, GAMP 5). Support audits and inspections by providing validation documentation. Test

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Full-time, Contract, Third Party

Travel Mammography Tech - $2,919 per week in Sewell, NJ

Mantua Township, New Jersey

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Today

Mammography Tech Location: Sewell, NJ Agency: Windsor Healthcare Recruitment Group, Inc. Pay: $2,919 per week Shift Information: Days - 5 days x 8 hours Contract Duration: 12 Weeks Start Date: ASAP About the Position AlliedTravelCareers is working with Windsor Healthcare Recruitment Group, Inc. to find a qualified Mammography Tech in Sewell, New Jersey, 08080! Local Rate Differential Shift is 7:30a-4:00p REQUIRED: BLS, ARRT (R), ARRT advanced certification in Mammography, and NJ state li

Full-time

USD 2,919.00 per week

Sr. CSV Engineer

Oregon City, California

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Today

Summary : Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies. Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems Create and modify validation documentation including but

Full-time

Development Mechanical Engineer

Broadview Heights, Ohio

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Today

Summary Proficiency in CAD (SolidWorksPTC Creo), GDT, tolerance analysis, and fixture design. Strong capability in test protocol report writing, statistical analysis (9595, tolerance intervals), and data integrity practices. Familiarity with materials and processes Ti alloys, CoCr, stainless steel, UHMWPE, PEEK, AM, coatings. Understanding of design controls, ISO 13485, ISO 14971, and regulatory pathways (510(k), PMA, MDR). Competence in risk management tools (DFMEA, pFMEA) and traceability from

Full-time

Software Embedded Engineer (Tecan/Evoware)

Phoenix, Arizona

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Today

This full-time, onsite opportunity in Gaithersburg, MD invites you to join a fast-growing medical device company that's transforming the pharmaceutical and diagnostic industries through innovative technology. As a Software Embedded Engineer, you'll work on embedded software and automation, developing solutions that power next-generation laboratory and medical instrumentation, including systems integrating Tecan/Evoware technologies for liquid handling and sample processing. If you're passionate

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Full-time

$130000 - $150000

Salesforce Project Manager

Remote

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22d ago

Key Responsibilities: Lead and manage end-to-end Salesforce projects across Life Sciences, Pharma, and Healthcare verticals.Collaborate with stakeholders to define project scope, objectives, and deliverables aligned with regulatory and operational requirements.Develop and maintain detailed project plans, schedules, and budgets.Ensure compliance with industry regulations such as HIPAA, GxP, and FDA guidelines.Coordinate with cross-functional teams including Salesforce developers, business analyst

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Contract

Depends on Experience

Systems Engineer

Clayton, North Carolina

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Yesterday

Systems Engineer Duration:17 Months+ Contract Location: Clayton, NC (Onsite) Position Description : A Systems Engineer is needed to support a site expansion project at site in Clayton, NC. The ideal candidate will provide Tier 1-2 operational support as part of a cross-functional IT Infrastructure team, as well as assist in the maintenance & administration of IT systems and network. The role will report to the IT Infrastructure Manager. Job Description: *Perform life-cycle system development

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Contract

40 - 48

Staff Medical Product Quality & Reliability Engineer

Wilmington, Massachusetts

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Today

About Analog Devices Analog Devices, Inc. (NASDAQ: ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world. With revenue of more than $9 billion in FY24 and approximately 24,000 people globally, ADI

Full-time

USD 106,500.00 - 159,750.00 per year

CSV Engineer

Bothell, Washington

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Today

Summary: Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies. Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems Create and modify validation documentation including but

Full-time

Graphics Software Engineer

Remote or Hybrid in Langhorne, Pennsylvania

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3d ago

Genzeon, an AI and automation company with deep engineering and data expertise, dedicated to serving the healthcare and retail industries. Our platform solutions including HIP One, CompliancePro Solutions, and Patient Engagement Solutions empower organizations to scale innovation and transform outcomes. Genzeon is a global community of innovators and problem-solvers, with a culture built on inclusion, flexibility, and purpose-driven work. With four global delivery centers, we support providers

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Contract, Third Party

Depends on Experience

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