FDA Jobs in San Jose, CA

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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 1 hour 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 1 day ago | Updated 1 hour ago

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
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Posted 26 days ago | Updated 11 days 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 5 days ago | Updated moments ago

Business developer Manager- Medtech/Healthcare

Showman Staffing

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Remote

Full-time

Job Title: Sr.Business Developer Manager Experience: 6+yrs Location: Remote-Travel required-100% client location-Candidates should be in USA Job: Permanent Full Time Requirement Role Overview We are seeking a passionate and driven Sales professional to accelerate our growth in the Healthcare and MedTech space one of the most rapidly evolving sectors today. You will work with a high performing team targeting innovative healthcare providers, MedTech firms, and digital health disruptors to bring c
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Posted moments ago

Computer System Validation Lead

Nityo Infotech Corporation

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Remote

Third Party, Contract

Job Details: 7-10 years experience in Computer System Validation of EMS and BMS applications Must have experience in Agile methodology and handled multiple releases in parallel Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation, experience with EMS/BMS, project management, test script review, test execution review, test defect management. Has working experience in any one or two of the following domains Tool validation like ServiceNOW, Automation tools, JIRA Gu
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Posted 3 days ago

Remote Care Technical Support Technician - Onsite

VIVA USA INC

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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
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Posted 4 days 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 moments 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 12 days ago

Statistical Programmer

Georgia IT

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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,
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Posted 4 days ago

LIMS - Laboratory Information Management Systems

Javen Technologies, Inc

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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
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Posted 4 days ago | Updated 22 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 2 days ago | Updated 4 hours 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 11 days ago | Updated 4 hours ago

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
Posted 16 days ago | Updated 4 hours ago

Senior Regulatory Affairs Specialist

ZennSoft

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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
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Posted 13 days ago

NPD Test Lead- Embedded systems, Mobile app

Sureminds Solutions

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Pleasanton, California, USA

Contract, Third Party

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
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Posted 27 days ago | Updated 25 days ago

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
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Posted 5 days ago

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
Posted 9 days ago | Updated 4 hours ago

Packaging Supervisor

Mice Groups

•

Livermore, California, USA

Full-time

Job Title: Packaging Supervisor Salary Range: $68,000 $80,000 Shift Preference: Swing shift preferred, but day shift is also an option Job Summary: The Packaging Supervisor oversees employees in a manufacturing and assembly setting. Responsibilities include planning work, enforcing safety and food standards, and improving production processes. Key Duties: Implement and manage production schedulesAssign and supervise line personnelCommunicate with staff about performance, scheduling, and qualityM
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Posted 10 days ago | Updated 5 days ago

Sr R&D Engineer - Shockwave

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
Posted 18 days ago | Updated 4 hours ago