- Cepheid (Sunnyvale, CA)
- …science field.Related work experience in Quality with a focus on assay development in a medical device or IVD l industry with applicable knowledge of FDA QSR, EU ... every test there is a patient waiting.Learn about the Danaher Business System which makes everything possible.The Sr. Quality Specialist is responsible for… more
- Meta (Burlingame, CA)
- …services, such as Meta AI and other wearable devices . **Required Skills:** Medical Devices , System Verification Engineer Responsibilities: 1. Design ... Verification and Validation Engineer to join our medical devices compliance team, focusing on wearables...to joining Meta 8. 3+ years of experience in medical device system engineering or… more
- Amgen (Thousand Oaks, CA)
- …standards and regulations: Quality System Regulation - 21CFR820; Quality Management System for medical device /component manufacturers - ISO 13485 Risk ... engineer will interact with global and multi-functional members from systems engineering, process engineering, device development, packaging,...Medical Devices - ISO 14971; EU Medical Device Regulation - 2017/745 **What you… more
- US Tech Solutions (San Bruno, CA)
- …align with Quality System procedures, utilizing expertise in the medical device product development life-cycle, Risk Management, Design/Process ... audit readiness and regulatory submissions. + Support bringing novel medical devices from concept to release, manage... Manufacturing or Software as a Medical Device (SaMD). + Experience with Quality Management Systems… more
- BD (Becton, Dickinson and Company) (Temecula, CA)
- …planning, performing, and analyzing bench-level engineering tests or research experiments for drug- device combination products and medical devices . The ... team. This position performs technical analyses of drug delivery systems , designs fixturing, develops and validates test methods, and...software such as Minitab and JMP + Knowledge of drug- device combination products and/or medical devices… more
- AbbVie (Pleasanton, CA)
- …Must have 1 year of quality engineering work experience in FDA regulated medical device manufacturing environment(s). If experience required, must have 1 year ... (QSR), ISO 13485, ISO 14971, MDR, & MDSAP; + performing all tasks according to medical device development life cycles, manufacturing processes & GMP; & + working… more
- J&J Family of Companies (Santa Clara, CA)
- …Development, execution, and documentation of test plans. + Development, execution and functional verification to medical device standards. + Initiate and ... aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease...devices . + Experience with lasers and pulse discharge systems a plus. + Operate as a team and/or… more
- AbbVie (Pleasanton, CA)
- …with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with ... our talent pipeline and considered for future opportunities. The Device Engineer will work collaboratively with a team to...* Prefer at least three years of experience in medical devices , ideally class II devices… more
- AbbVie (Irvine, CA)
- …with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with ... our talent pipeline and considered for future opportunities. The Device Engineer will work collaboratively with a team to...* Prefer at least three years of experience in medical devices , ideally class II devices… more
- Actalent (Irvine, CA)
- …THIS IS NOT A SOFTWARE POSITION Looking for hands on IQ/OQ/PQ Validation in Medical Device Candidates MUST HAVE + Bachelor of Science in Engineering or ... and perform validations for current and anticipated projects. + Ensure appropriate systems are in place to evaluate changes to validated/qualified systems ,… more
- Amazon (Sunnyvale, CA)
- …solutions for integration into Amazon's products, services, and operations. The Lead Systems HW Engineer is responsible for system impact assessment and ... a highly skilled and innovative Lead Hardware Engineer to join our Amazon Device Climate Tech Accelerator program. This role will be instrumental in driving the… more
- US Tech Solutions (San Bruno, CA)
- …for medical devices , specifically focusing on Software as a Medical Device (SClient) or low-risk enforcement discretion products. 2. At least 3-5 ... System Regulations, ISO 13485, and integration of best practices from the medical device industry. **Documentation and Support:** 1. Support the creation and… more
- Meta (Sunnyvale, CA)
- …develop industry leading Machine Learning IP's optimized for Mixed Reality and Smart Devices and use-cases, defining verification methodologies for each of the ... levels 3. Implement scalable test benches including checkers, reference models, assertions in System Verilog 4. Drive Design Verification to closure based on… more
- Amazon (Sunnyvale, CA)
- …innovative Silicon IP AZ1 Neural Edge that is powering the latest generation of Echo devices is looking for a Senior Design Verification Engineer to continue to ... methodology and implementing the corresponding test plan for sub- systems and the full chip. You will participate in...across multiple disciplines - Deliver detailed test plans for verification of the full chip or sub- system … more
- Amazon (Sunnyvale, CA)
- …EE, CE, or CS - 5+ years or more of practical semiconductor design verification experience including System Verilog, UVM, assertions and coverage driven ... that is exploring new hardware designs to improve our devices . In this role, you will be responsible for...platforms: UVM test bench, FPGA, emulator, software environments and system testing - Track record of defining verification… more
- Philips (San Diego, CA)
- **Senior/Staff Digital Electrical Engineer** **- FPGA for Medical Devices (San Diego, CA)** As a member of an international cross-functional team, you work ... Biomedical Engineering, or a related field. Experience applying IEC 60601-1 and related medical device electronics standards is desirable. + You must be able… more
- Meta (Sunnyvale, CA)
- …based verification and UVM methodology 10. 2+ years experience in IP/sub- system and/or SoC level verification based on SystemVerilog UVM/OVM based ... map the human body. Our chips will enable AR devices where our real and virtual world will mix...through architecture, to firmware, and algorithms. As a Design Verification Engineer at Meta Reality Labs, you will work… more
- Amazon (Sunnyvale, CA)
- …the best-selling Kindle family of products. Since then, we have produced groundbreaking devices like Fire tablets, Fire TV and Amazon Echo. What will you help ... us create? As a Sr. Design Verification Engineer at Amazon, you will be part of...research team that is building world class hardware for devices . The ideal candidate should have experience with RTL… more
- Meta (Sunnyvale, CA)
- …sensors, and new ways to map the human body. Our chips will enable AR & VR devices where our real and virtual world will mix and match throughout the day. We believe ... entire stack, from transistors, through architecture, firmware, and algorithms. As a Design Verification Manager at Meta Reality Labs, you will work with and support… more
- Amazon (Sunnyvale, CA)
- …the team which delivers highly differentiated silicon into Blink and Ring battery powered devices . Our verification team works on state-of-the art SoCs in a ... and sub- systems for testability/verifiability - Write comprehensive block and system level testplans - Build assertions, traffic generators and scoreboards -… more
