Fda jobs in santa clara, ca

Remote

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7d ago

POSITION TITLE:Information Technology Specialist - FDA LOCATION:Remote CLEARANCE:Must be able to obtain aHigh-RiskPublic Trust COMPANY OVERVIEW At APV,weremore than a technology company werea mission-driven powerhouse transforming organizations through advanced technology and human ingenuity. Ourexpertisespans AI/ML, data architecture, low-code/no-code development, AgileDevSecOps, and cloud services, delivering scalable and meaningful solutions. In our Emerging Technology Lab, innovation drive

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Contract

Depends on Experience

C++ Developer - Medical Device - Las Gatos, CA

Santa Clara, California

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12d ago

Senior Software Engineer (C++) Location: Los Gatos, CA (On-site) Role Overview Seeking a Senior Software Engineer to play a key role in the design, development, and verification of software for a safety-critical medical device system. This role requires strong technical expertise, attention to quality and regulatory standards, and the ability to collaborate across multidisciplinary teams in a fast-paced startup environment. Key Responsibilities Design, develop, and maintain high-quality softw

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Contract

Depends on Experience

Manufacturing Engineer

Pleasanton, California

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2d ago

Position: Manufacturing Engineer Location: Pleasanton, CA Opening: 1 Job Summary: 5+ years of Medical device Manufacturing experience Support in Manufacturing process remediation and readiness activities for new product launch.Support Design Transfer deliverables, including tracking and scheduling.Support/Initiate Change Order for manufacturing documentation such as but not limited to, manufacturing procedures, shop floor paperwork, and inspection procedures.Risk Management updates PFMEA.Part

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Contract, Third Party

40 - 45

Regulatory Affairs Specialist 4

Sunnyvale, California

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2d ago

Primary Function of Position The Sr. Regulatory Affairs primary responsibilities include developing regulatory plans, reviewing design input/output documentation, identification of applicable standards and guidance documents, performing regulatory assessments to determine the impact of design/process changes, preparing regulatory submissions, maintaining regulatory filings and licenses. Essential Job Duties Provide regulatory guidance to product teams, develop regulatory plans, a

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Third Party, Contract

$60 - $60

Senior Android Developer

Remote

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6d ago

HiAssociate, Greetingsfor theday, We have a position as aSenior Android Engineerrole forRemote.Please find the job description below for this position. Role:Senior Android Engineer Location: Remote Duration: 24 Months Note: Healthcare or Medical Device experience is mandatory. Key Responsibilities: Triage and debug field issues reported by users of our Android applications. Analyze crash reports, logs, and other diagnostic data to identify the root cause of issues. Develop understanding of ex

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Contract

Depends on Experience

SAP QM Architect

Remote

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26d ago

SAP QM ArchitectThe SAP Quality Management (QM) Architect leads the design, implementation, and optimization of SAP QM solutions in a regulated medical device manufacturing environment. The role requires deep expertise in QM processes, strong cross-module integration skills, and hands-on experience across implementations, rollouts, and upgrades. The architect ensures quality processes meet FDA/ISO standards and seamlessly integrate with manufacturing, supply chain, and compliance systems. Respon

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Contract

Depends on Experience

Regulatory Specialist

Remote

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2d ago

Job Title:Regulatory Specialist Location:Rosemont, IL - Remote Duration: Long Term Contract Key Responsibilities: Provide strategic input and technical guidance on regulatory requirements to R&D project teams. Develop and implement regulatory strategies to facilitate the progress of US and Global programs and initiatives for the company. Evaluate regulations, establish framework, and design and implement science-based registration strategies for company products to ensure rapid, high-quality s

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Contract

Depends on Experience

Senior Extrusion Engineer

Santa Clara, California

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4d ago

Title: Senior Extrusion Engineer Location: Santa Clara, CA Job Type: Permanent/Direct-Hire Compensation: $100,000 - $150,000 + bonus (annually) Industry: Medical Device Manufacturing About the Role Our recruiting firm is partnering with a leading medical device manufacturing organization to identify a Senior Extrusion Engineer. This company specializes in the development and manufacture of high-precision components used in minimally invasive medical devices, catheter-based systems, and other

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Full-time

Depends on Experience

Auditor

Remote or Chicago, Illinois

•

Today

Job Title: Quality Auditor Locations: Remote (50 - 60% Travel is expected anywhere in US but that will be sponsored) Duration: 6 months Contract Pay Range: $40 - $43/hr. Must Have's 8+ years of Quality Assurance and Quality Auditing experience within the medical device or pharmaceutical industry Extensive experience leading supplier/vendor audits from planning through final reporting Expert knowledge of FDA regulations (21 CFR Parts 210, 211, and 803), ISO 13485, and Quality Management Systems

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Full-time

$40.0000 - $43.0000

Clinical Research Scientist III - (Director/Assoc. Director level)

Remote or Hybrid in Parsippany-Troy Hills, New Jersey

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10d ago

Acquires and utilizes knowledge of clinical trial design to develop specific study concept sheets and protocols. Participates in protocol review discussions concerning scientific and procedural aspects of study design. Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed with appropriate guidance and supervision. With supervision, contributes to the design and development of CRFs, Data Management Manuals and Da

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Third Party, Contract

$100 - $110

Senior Software Engineer

San Jose, California

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26d ago

Job Title: Senior Software Engineer Location: San Jose, CA Type: Contract Compensation: $70.00 per hour Work Model: Type: Onsite In-Person all working days Location:(California, San Jose) Shift: 9-5 Responsibilities Develop and execute comprehensive test plans and strategies for embedded software, firmware, and hardware-integrated products. Analyze requirements and create detailed test cases, test plans, and test protocols. Conduct manual and automated testing of embedded systems, ensuring thor

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Contract

$65

Services Project Manager

Hybrid in Sunnyvale, California

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4d ago

Job title : Project ManagerLocation : Sunnyvale, CA (Hybrid)Duration : 1 year Job Description :Primary Function of Position:The Project Manager is accountable for providing cross-functional project management on behalf of the Global Services Business Unit (GSBU) in support of new product development/introduction and executing key strategic initiatives. The Project Manager serves as the primary liaison between ISI's Engineering teams / Engineering PMO and the Field Service, Technical Support, Cus

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Contract

$70 - $85

QA Test Engineer

Remote

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24d ago

Blu Omega is seeking a QA Test Engineer to support a federal program focused on data validation and workflow testing within the FDAs Regulated Product Submission (RPS) program. This role operates in a remote environment and is responsible for executing functional, integration, and data verification tests. The position requires experience supporting testing efforts in a mission-driven environment, with a focus on data accuracy, integrity, and consistency. Program Overview Program: FDA Regulated P

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Full-time

125,000 - 135,000

Clinical Information Specialist with Womens Health Clinical Practice (W2 ONLY)

Remote

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Today

Clinical Information Specialist / W2 ONLY / REMOTE / Contract Role About our Customer & Role: Our DIRECT customer, a global leader in Pharmaceutical industry is seeking an experienced Clinical Information Specialist with at least 5 years of experience, in Women s Health Clinical Practice. The Clinical Liaison acts as a liaison for healthcare providers, supporting the clinical use of implantable contraception for trained clinicians with Nexplanon. Education / Certificates: Licensed Advanced Pra

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Contract

Depends on Experience

CMO Digital Liaison & Data Steward

Remote

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Today

Business Analyst / Digital Steward CMO Connections Role Overview We are seeking a technically grounded Business Analyst / Digital Steward to support digital connections with external Contract Manufacturing Organizations (CMOs). This person will help own the digital engagement with external manufacturing partners end to end from partner onboarding and tech transfer through commercialization and long-term sustainment of inline products. The role operates across a matrixed portfolio of strategic CM

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Contract

Depends on Experience

SAP Security Consultant - Remote

Remote

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4d ago

Title: SAP Security Consultant - Remote Mandatory skills: SAP GRC, AC/PC, SAP BTP Technologies, enterprise-wide system solutions, SAP Security Role Design, user administration, SAP security requirements, SOX, FDA validation, SAP authorization management, SHS compliance requirements, SAP Audit Management, SAP ECC, S/4 HANA, SAP HANA, SAP BI NetWeaver, Fiori, SAP RISE, SAP GTS, SAP NFP, SAP MES, SAP BI systems, supporting tools, Security Weaver, SHARP, SAP role management, SAP Identity Management,

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Contract

52 - 57

Validation Engineer

San Jose, California

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Today

Summary: In this position, you will be responsible for the planning, execution, and documentation of validation protocols (IQ/OQ/PQ) for medical device manufacturing processes and equipment. You will work cross-functionally to ensure the products meet the highest quality standards. Roles & Responsibilities: Develop and execute validation plans and reports. Analyze data and troubleshoot process deviations. Ensure compliance with FDA regulations and ISO standards. Collaborate with Engineering an

Full-time

Manufacturing Engineer (W2 & C2C)

Pleasanton, California

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3d ago

Position: Manufacturing Engineer Location: Pleasanton, CA (100% onsite) Contract Duration: 12+ months/ Long Term Openings: 2 Visa Details: H1b/OPT/USC Job Summary: 4+ years of Medical device Manufacturing experienceSupport in Manufacturing process remediation and readiness activities for new product launch.Support Design Transfer deliverables, including tracking and scheduling.Support/Initiate Change Order for manufacturing documentation such as but not limited to, manufacturing procedures, sho

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Contract

Depends on Experience

Staff/Principal Software Engineer - Medical Imaging & Robotics

Campbell, California

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Today

ABOUT SHIFAMED Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical technology incubator focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology. Description: As a Staff/Principal Software Engineer, you will engineer the intelligence behind a revolutionary robotic platform with ultrasound imaging and AI for interventional cardiology. You will work at the challenging i

Full-time

USD 170,000.00 - 220,000.00 per year

Staff Reliability Engineer Hardware

San Jose, California

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Today

Role: Staff Reliability Engineer Hardware Experience: Minimum 6+ Years Location: San Jose, CA Work Mode: Onsite 5 Days a Week We are looking for an experienced Staff Reliability Engineer to support product reliability, verification, validation, and design improvements for medical devices. The role involves developing and executing reliability test strategies, supporting new product development, and ensuring compliance with quality and regulatory standards. Responsibilities Develop and exe

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Third Party

Fda jobs in Santa Clara, CA, USA