FDA Jobs in San Jose, CA

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Sr 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: We are a full-service engineering consulting firm providing services for a broad range of projects and clients within the private and public marketplaces. Our design engineers provide cost-conscious, reliable, HVAC, plumbing

Lead Embedded Software Engineer (Modern C++)

Oxford Global Resources

Milpitas, California, USA

Contract

Position Title: Lead Embedded Software Engineer (Modern C++) Location: Milpitas, CA onsite 4 days a week, 1 day remote Length of Contract: 12 months to start, contact-to-hire Ideal Start Date: 7/7/25 Interview Process: There will be initial screen by hiring manager for 30-45 minutes, then there will be a Test assessment on your Modern C++ , then an onsite interview round will be onsite with the team, other engineers, etc. Background Check Required Scope: We have a Long-standing Oxford clie

Lead IT Validation Consultant

Amaze Systems Inc

New York, USA

Third Party, Contract

Lead IT Validation Consultant Remote Notes : Prior experience in CROs, clinical research organizations, or pharmaceutical/biotech companies. Knowledge of laboratory processes such as PK, TK, and biomarker studies. Experience with integration of LIMS with other lab or enterprise systems (e.g., CDS, ELN, CTMS).Validation or QA certifications a plus. JD: We are seeking an experienced IT Validation Consultant to lead and support the validation of Laboratory Information Management System (LIMS) used

Technical Writer Asset Management Systems (Life Sciences) - Remote

DivIHN Integration Inc.

US

Contract

DivIHN (pronounced divine ) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent. Visit us at to learn more and view our open positions. Please apply o

Business Analyst

NTT DATA Americas, Inc

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

Remote Care Technical Support Technician - Onsite

VIVA USA INC

Pleasanton, California, USA

Contract

Title: Remote Care Technical Support Technician - Onsite Mandatory skills: Clinical, lab, MS Word, Excel, Outlook, Customer service, Calls, Call Support, Remote Care Technical Support, business environment, customer issues, Medical, medical systems, medical environment, capital equipment systems, human capital utilization, R&D, Technical Services, patients, clinics, clinical applications, software support, field services, field service support, quality standards, quality system, quality actions

LIMS and QC Applications Consultant

Expedite Technology Solutions

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

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

Document Management Specialist | Remote | Contract

Walker Healthforce

Remote

Contract

Document Management Specialist | Remote | Contract Walker Healthforce is seeking a Document Management Specialist with +4 years of experience. This is a contract opportunity. CORE REQUIREMENTS:An A.A. in Business or English (or related) with four (4) years of experience OR Bachelor of Arts degree.Strong writing skills with good grammar.Attention to detail.Able to work on multiple documents in parallel.Able to create simple forms and templates.Must be able to use MS Office tools and interact with

Statistical Programmer

Georgia IT

Remote

Contract

Statistical Programmer Remote Duration: 12+ Months Rate: DOE Key responsibilities At least 5 years of experience in ADaM/TLF.Create, validate, and maintain SAS programs for data analysis, reporting, and submission deliverablesDevelop analysis datasets (ADaM) and tables, listings, and figures (TLFs) to support statistical analysis in production side.Collaborate with statisticians and data managers to define dataset specifications and outputsEnsure compliance with internal SOPs, CDISC standards,

LIMS - Laboratory Information Management Systems

Javen Technologies, Inc

Remote

Contract, Third Party

Experience with LIMS (Laboratory Information Management Systems) preferably LabVantage Understanding of clinical, research, or diagnostic lab workflows Knowledge of regulatory requirements (GxP, FDA 21 CFR Part 11) Familiarity with lab instruments, integrations, and data flows Working with ELNs (Electronic Lab Notebooks) and lab automation Basic understanding of data security, validation, and integrity in lab system Skills: Business Analysis Skills: Requirements gathering and documentation Proce

SAP Developer Lead Remote Location

Sierra Business Solution LLC

Remote

Third Party, Contract

Job Description: >> Lead SAP development projects and provide technical guidance across modules and platforms. >> Manage and coordinate activities of an offshore SAP development team, ensuring high-quality deliverables. >> Develop, enhance, and maintain SAP applications using SAP Workflow, FioriUI5, Web Dynpro (ABAPJava), SAP Enterprise Portal, BRF+ (Business Rule Framework Plus), LSMW (Legacy System Migration Workbench). >> Perform root cause analysis and debugging of complex SAP issues across

Statistical Programmer & Senior Biostatistician

Interpro Inc.

Remote

Contract

Interpro has been in the IT consulting business since 1993 and our employees work on a range of projects across the country.We have a long-term opportunity as described below: Remote working-EST hours Statistical Programmer Key responsibilities At least 5 years of experience in ADaM/TLF.Create, validate, and maintain SAS programs for data analysis, reporting, and submission deliverablesDevelop analysis datasets (ADaM) and tables, listings, and figures (TLFs) to support statistical analysis in pr

System Validation Engineer

Katalyst Healthcares and Lifesciences

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

Medical Device & Regulations Engineer

Katalyst Healthcares and Lifesciences

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

CSV Engineer

Katalyst Healthcares and Lifesciences

Santa Clara, California, USA

Full-time

Job Description: The CSV Engineer will play a critical role in ensuring that all computerized systems used in the manufacturing and quality systems of medical devices are validated according to applicable regulations such as FDA 21 CFR Part 11, EU Annex 11, and ISO 13485. This role ensures the systems are compliant, reliable, and fit for intended use, supporting quality and regulatory requirements across the organization. Responsibilities: Develop and execute Computer System Validation (CSV) de

Senior Regulatory Affairs Specialist

ZennSoft

Union City, California, USA

Full-time

Job Title: Senior Regulatory Affairs (RA) Specialist Location: Union City, CA Industry: Medical Devices / Regulatory Affairs Employment Type: Full-Time Client: Lhasa OMS, Inc. About the Role Lhasa OMS, Inc. is seeking a highly motivated Senior Regulatory Affairs Specialist to join our team in Union City, CA. The ideal candidate will support the Regulatory Affairs department by preparing and submitting regulatory documentation for medical devices in both domestic and international markets. This p

NPD Test Lead- Embedded systems, Mobile app

Sureminds Solutions

Pleasanton, California, USA

Third Party, Contract

C2C Role Please share Profiles at Hi, Urgent need, Position- NPD Test Lead- Embedded systems, Mobile app (5 days per week onsite ) Location: Pleasanton, CA (Need only Local.) Note- Must to have Medical Domain background NPD Test Lead- Embedded systems, Mobile app to drive the Test strategy , test automation and introduction of cutting-edge medical devices. This role demands deep technical expertise in embedded software, Mobile test automation, regulatory compliance, and cross-functional leade

Sr. R&D Electrical Systems Engineer (Med Device)

Oxford Global Resources

Santa Clara, California, USA

Contract

Title: Sr. R&D Electrical Systems Engineer Length of Contract: 4-6 Months + possible extension Location: Santa Clara, CA Onsite only. Ideal Start Date: Targeting August 11 or August 18, 2025 Interviews: 2 rounds, 1 on 1 first round, panel second round (onsite if local and willing for second round) True Timeslots: Tuesday July 29 1pm-3pm PST Reason for Needing a consultant: The client requires hands-on electrical engineering support to assist with ongoing troubleshooting and root cause analysis e

Sr Ultrasound Acoustic Engineer - Shockwave Medical

Johnson & Johnson

Santa Clara, California, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m