fda Jobs in california

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Senior UX Designer, Product Development - Medical Devices/FDA

One IT Corp

•

Remote

Contract

Senior UX Designer, Product Development Duration: 12+Months Required Location: Remote with travel to Naples, FL once a Quarter PAID FOR BY THE CLIENT. Opportunity Type: Contract-to-Hire A senior UX Designer with Recent Medical device experience and a recent Portfolio. Candidates must have experience working within FDA-regulated environments or equivalent. interfaces for products governed by FDA, ISO 13485, IEC 62304, or similar standards. Must have experience designing for FDA-regulated or equ
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Posted 2 days ago

Sr Mechanical/Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)

Jobot

•

US

Full-time

Sr Process Design Engineer / Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast) This Jobot Job is hosted by: Tony Barhoum Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $115,000 - $150,000 per year A bit about us: Full-Service Engineering Consulting Firm with a broad range of projects and clients within the private and public marketplaces. Our design engineers provide cost-conscious, reliable, Design/Build Solutions to meet our Clients
Posted moments ago

Sr Mechanical/Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)

Jobot

•

US

Full-time

Sr Mechanical/Process Design Engineer - Technical Lead (Cleanrooms/Pharma/Healthcare/cGMP) - Remote (East Coast Preferred) This Jobot Job is hosted by: Tony Barhoum Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $115,000 - $150,000 per year A bit about us: Full-Service Engineering Consulting Firm with a broad range of projects and clients within the private and public marketplaces. Our design engineers provide cost-conscious, reliable, Des
Posted moments ago

Business Analyst

NTT DATA Americas, Inc

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Remote or Pittsburgh, Pennsylvania, USA

Contract

Company Overview: Req ID: 328701 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. NTT DATA's Client is currently seeking a Cybersecurity Business Analyst to join their team in Pittsburgh, Pennsylvania (US-PA), United States (US). (REMOTE)Job Description: Experience Level: 7-9 years of relevant experience Role Overview: The Business Analyst (BA) wil
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Posted 8 days ago | Updated 11 hours ago

LIMS and QC Applications Consultant

Expedite Technology Solutions

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Remote or Bridgewater, New Jersey, USA

Full-time, Contract

Solution Architecture and Design: Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, ELN, SDMS). Define data models, interface designs, and system configurations. Implementation and Deployment: Oversee installation, configuration, and validation of LabVantage LIMS applications. Develop and execute project plans, ensuring timely an
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Posted 60+ days ago | Updated 11 hours ago

Senior Software Engineer

General Motors

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Mountain View, California, USA

Full-time

Job Description Remote: This role is based remotely but if you live within a 50-mile radius of Mountain View, you are expected to report to that location three times a week, at minimum. The Role: The develops the first layers of software on the car, from interfacing with hardware, to moving large amounts of data up the software stack. As a Senior Software Engineer you'll be responsible for designing, documenting, and implementing complex, highly scalable, low-latency software on Linux-based sy
Posted 2 days ago | Updated 1 hour ago

Windchill Consultant

Teknikoz

•

Sunnyvale, California, USA

Contract, Third Party

PTC Arena Consultant Job Description:We are seeking a skilled and proactive PTC Arena Consultant with a minimum of 3 years of hands-on experience in Arena PLM/QMS systems. The ideal candidate will play a key role in supporting, configuring, and enhancing Arena PLM to meet our product development and compliance needs. You will collaborate with cross-functional teams including Engineering, Quality, Regulatory, and Manufacturing to ensure smooth implementation and ongoing optimization of Arena s
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Posted 15 days ago

Component Engineer - Validation (IQ/OQ/PQ)

Katalyst Healthcares and Lifesciences

•

Irvine, California, USA

Full-time

Job Description: Experienced Component Engineer with strong expertise in equipment and process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Proven ability to manage component selection, supplier coordination, and quality documentation to ensure compliance with FDA, ISO 13485, and GMP standards. Roles & Responsibilities: Component validation activities including creation and execution of IQ/OQ/PQ protocols and reports.
Posted 11 days ago | Updated 3 hours ago

R&D Engineer with Medical Device

Katalyst Healthcares and Lifesciences

•

Irvine, California, USA

Full-time

Job Description: We are seeking a motivated and innovative R&D Engineer to support the design, development, and testing of medical devices in compliance with FDA and ISO standards. The ideal candidate will work closely with cross-functional teams to bring new products from concept to commercialization. Responsibilities: Design and develop medical devices and components from concept to production. Create design inputs, outputs, risk analysis, and test protocols. Perform design verification and
Posted 8 days ago | Updated 3 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Santa Clara, California, USA

Full-time

Roles & Responsibilities: Software quality assurance or software validation. Preferably within the medical device industry. Strong knowledge of FDA 21 CFR Part 820, ISO 13485, IEC 62304. Experience in non-product software validation. Includes tools for development, testing, maintenance. Deep understanding of quality standards and regulatory requirements: FDA 21 CFR Part 820. ISO 13485. IEC 62304. Software quality assurance. Software validation. Non-product software tools (for testing
Posted 5 days ago | Updated 3 hours ago

Validation Engineer/CSV Engineer

Katalyst Healthcares and Lifesciences

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Walnut Creek, California, USA

Full-time

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 applicabil
Posted 3 days ago | Updated 3 hours ago

Engineer III, Systems Engineer

Katalyst Healthcares and Lifesciences

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San Diego, California, USA

Full-time

Responsibilities: Verification & validation Engineer will have the following responsibilities: A strong technical background and experience g in the medical device industry (Translation of User/Business Needs to System Requirements, Requirements Management, System Architectural Development, Functional Modeling, Systems Integration, Statistical Test Design, Verification and Validation, Hazards Analysis, and Failure Modes Effects Analysis), and/or other engineering disciplines within the medical
Posted 28 days ago | Updated 3 hours ago

Data Science/ML Engineer

People Force Consulting Inc

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Remote

Contract

We are seeking a highly skilled Senior Machine Learning Engineer to join the Foundational Data Analytics (FDA) Program, a strategic initiative focused on building a modern, intelligent data ecosystem. This role will lead the design, development, and deployment of machine learning models that support enterprise-wide analytics, predictive insights, and healthcare transformation. FDA Program Objectives: Single Source of Truth (SSOT): Build standardized, high-quality data infrastructure ensuring con
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Posted 8 days ago | Updated 1 hour ago

Statistical Programmer

Georgia IT

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Remote

Contract

Job Title: Statistical Programmer Location: Remote Key Responsibilities Develop, validate, and maintain SAS programs for statistical analysis, regulatory submission, and reporting deliverables. Create analysis datasets (ADaM) and tables, listings, and figures (TLFs) for clinical trial data analysis. Collaborate with statisticians and data managers to define specifications for datasets and statistical outputs. Ensure compliance with CDISC standards, internal SOPs, and regulatory guidelines (FDA,
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Posted 6 days ago

System Validation Engineer

Katalyst Healthcares and Lifesciences

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Santa Clara, California, USA

Full-time

Responsibilities: 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 applicabi
Posted 14 days ago | Updated 3 hours ago

Senior Biostatistician: Pharma experience / Remote

Biogensys

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Remote

Contract

Biogensys is currently hiring Senior Biostatistician with Pharma experience for 6 to 12 months contract on w2. This is a remote position, no corp to corp, or 1099. No sponsorship is available. Senior Biostatistician: Pharma experience / Remote- At least 9-10 years of experienceLead statistical aspects of clinical studies from design to final reportingReview and approve programming deliverables (ADaM datasets, tables, listings, and figures)Proven expertise in SAS and/or R for statistical analysis
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Posted 9 days ago

Regulatory CMS Senior Manager

Sureminds Solutions

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Remote

Contract, Third Party

C2C Role Please share Profiles at Hi, Urgent need, Job Title: Regulatory Studio CMS Senior Manager Work location: New Brunswick (preferred), Lawrenceville Monday thru Friday - Normal business hours, with some flexibility 50% onsite - Team is onsite Monday thru Thursday Top 3 to 5 skills/Must Haves: Small Molecule Drug development experience (2 to 3 years) Good communications skills (written/verbal) Experience with Veeva System PREREQUISITES BS/BA degree in Scientific Discipline (master's or hig
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Posted 3 days ago | Updated 2 days ago

Medical Device & Regulations Engineer

Katalyst Healthcares and Lifesciences

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Santa Clara, California, USA

Full-time

Responsibilities: 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 applicabil
Posted 19 days ago | Updated 3 hours ago

Director, Clinical Quality Assurance

IO Associates

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Remote

Full-time

Director, Clinical Quality Assurance Location: Flexible (US-based) A rapidly growing biotech company advancing cutting-edge therapies for rare diseases is seeking a Director of Clinical Quality Assurance (CQA) to build and lead its Google Cloud Platform compliance strategy. Reporting to the Head of Quality, this is a high-impact leadership role responsible for designing and executing clinical quality systems across a portfolio of global early-phase gene therapy trials. Key Responsibilities: Le
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Posted 7 days ago | Updated 1 hour ago

Senior Outcomes Specialist

E-Solutions, Inc.

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California, USA

Third Party

Job title: Senior Outcomes Specialist Location: Remote Mandatory Skills: SQL, SAS, R, or Python, Healthcare What's in it for you :- We are seeking a results-driven and analytical Senior Outcomes Specialist to support the Foundational Data Analytics (FDA) Program. This role will focus on measuring, analyzing, and improving clinical, operational, and financial outcomes across the enterprise. The ideal candidate will bring deep expertise in healthcare analytics, outcomes measurement, and perfor
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Posted 3 days ago | Updated 14 hours ago