14 results (1 new)
San Diego, California
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Today
8+ years of Validation & Verification experience within the medical device industry. Proven experience serving as a Validation Subject Matter Expert (SME). Extensive hands-on experience authoring and executing: IQ OQ PQ Computerized System Validation (CSV) Software Validation System Validation Strong understanding of: FDA 21 CFR Part 820 ISO 13485 ISO 14971 Medical Device Quality Systems
Third Party, Contract
$55 - $60
San Diego, California
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Today
Title: Senior Design Quality Engineer Location: Rochester, NY or San Diego, CA Duration: 12 Months The Position The Senior Design Quality Engineer (Hardware & Software) is a senior individual contributor within QuidelOrtho's Global Quality & Compliance (GQ&C) organization. This role provides technical support in the execution, oversight, and continuous improvement of Quality systems, processes, and programs that enable compliant product development and supporbusiness agility, innovation, an
Easy Apply
Contract
$65
San Diego, California
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5d ago
Scalable Systems is a USA based Big Data, Analytics and Digital Transformation company focused on vertical specific innovative solutions. By providing next generation technology solutions and services, we help organizations to identify risks & opportunities, achieve operational excellence and to gain an innovative edge.Job Role Validation Engineer (Medical Device) Location San Diego, CA (Day 1 Onsite) Role Descriptions: Must Have Technical/Functional Skills Must-Have Skills St
Easy Apply
Contract, Third Party
$35 - $40
Remote or New Jersey
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Today
Summary: We are seeking highly skilled and experienced System Engineers to join our team. The ideal candidate will have 5-8 years of experience in the medical device industry, with a strong focus on Design Controls, traceability, and design validation. This individual will play a critical role in ensuring that user needs are clearly traced to design inputs, verification, and validation throughout the product development lifecycle. Roles & Responsibilities: Design Controls: Lead efforts to deve
Full-time
Remote or Plymouth, Minnesota
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Today
Summary The Systems Engineer will support the overall technical direction of Acute Therapies products. This role involves contributing across the full product development lifecycle-from feasibility to post-market-focusing on requirements management, risk analysis, system integration, and verification/validation within a regulated medical device environment.Roles & Responsibilities: Support systems engineering activities across all product lifecycle stages (NPD to post-market) Translate clinical
Full-time
Remote or Salt Lake City, Utah
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Today
Summary: We are seeking a highly skilled R&D/Validation Engineer with mandatory experience in the Medical Devices domain. The ideal candidate will be responsible for planning, leading, and coordinating project execution and validation activities in strict alignment with ISO 13485 and ISO 14971 standards. This role requires a hands-on leader who can manage equipment, process, and product transfers while liaising with global teams and customers to ensure on-time delivery. Roles & Responsibilities
Full-time
Remote or Salt Lake City, Utah
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Today
We are looking for an experienced Validation Engineer with a strong background in the Medical Device industry to support validation and project execution activities. Key Requirements: bachelor's degree in mechanical engineering Prior experience in the Medical Device domain (Mandatory) Strong knowledge of ISO 13485 and ISO 14971 Experience with IQ, OQ, and PQ validation activities Validation planning, execution, and documentation Equipment, process, and product transfer validation experience Cr
Full-time
Remote or Pittsburgh, Pennsylvania
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Today
Roles and Responsibilities: The Product Industrialization Test Engineer supports the transition of medical device products from design to manufacturing by developing, optimizing, and industrializing test and production processes. The role focuses on improving manufacturing efficiency, implementing Lean Manufacturing principles, managing manufacturing documentation and Bills of Materials, and supporting process, tooling, and equipment enhancements. Responsibilities include executing test protocol
Full-time
Remote or Tucson, Arizona
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Today
Summary : We are seeking a proactive Validation Engineer with in a regulated manufacturing environment (medical devices, pharma, or biotech, preferably FDA) to ensure compliance and drive operational integrity. This is an on-site position that focuses on equipment validation. Roles & Responsibilities Develops, prepares, and executes IQ, OQ, and PQ protocols and reports for equipment/systems. Conducts risk assessments and develops qualification strategies for new and existing equipment/systems. n
Full-time
Remote or Tucson, Arizona
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Today
Job Description: We are seeking a proactive Validation Engineer with 1-3 years of experience in a regulated manufacturing environment (medical devices, pharma, or biotech, preferably. FDA) to ensure compliance and drive operational integrity. This is an on-site position that focuses on equipment validation.Responsibilities: Develops, prepares, and executes IQ, OQ, and PQ protocols and reports for equipment/systems. Conducts risk assessments and develops qualification strategies for new and exist
Full-time
San Diego, California
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Today
Company: Qualcomm Technologies, Inc. Job Area: Engineering Group, Engineering Group > Hardware Engineering General Summary: This individual independently plans and performs moderately-defined responsibilities related to the design and validation of electronic systems, circuits, components, integrated circuitry, equipment, and packaging. Conducts validation and analysis of designs. Evaluates, characterizes, and develops manufacturing solutions for leading edge products using advanced semicondu
Full-time
USD 113,947.00 - 166,900.00 per year
Remote or Springfield, Massachusetts
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Today
Job Description: Client is looking for onsite Validation Engineers / CQV Engineers to support upcoming qualification work tied to sterile manufacturing and fill/finish operations. The consultants will support hands-on OQ/PQ execution, GMP documentation, protocol execution, discrepancy/deviation support, and equipment qualification activities. The ideal candidate will have direct validation engineering or CQV experience in a fast-paced GMP environment, with strong exposure to fill line qualificat
Full-time
Remote or Rock Hill, South Carolina
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Today
Job Description: Senior Validation Engineer with experience supporting commissioning, qualification, and validation activities for process equipment in GMP-regulated environments. Responsible for executing IQ/OQ protocols, equipment verification, temperature mapping, SIP/CIP validation activities, deviation support, and ensuring compliance with GMP/GDP standards while collaborating with Engineering, QA, and Operations teams. Roles & Responsibilities: Execute Installation Qualification (IQ) and
Full-time
Remote or Massachusetts
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Today
Job Description: Senior CQV Engineer / Senior Validation Engineer with experience supporting commissioning, qualification, and validation activities for process equipment in GMP-regulated environments. Responsible for executing IQ/OQ protocols, equipment verification, temperature mapping, SIP/CIP validation activities, deviation support, and ensuring compliance with GMP/GDP standards while collaborating with Engineering, QA, and Operations teams. Roles & Responsibilities: Execute Installation Q
Full-time
