- Abbott (Alameda, CA)
- …Regulatory Affairs Certification (RAC) is a plus. + Experience with either 510(k) applications , PMA supplements, NDA, BLA, US Device regulations, US Combination ... regulations, US Drug regulations or with EU and other international medical device regulations and submissions. + Familiar with relevant regulatory requirements for… more
- Fortive Corporation (Irvine, CA)
- …with sites to manage ongoing project expectations and issues. + Evaluate the quality and integrity of study site practices related to the proper conduct of ... the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. + Manage the progress of assigned studies by tracking regulatory… more
- Fujifilm (Santa Clara, CA)
- …These are part of the digitization and transformation of many applications such as commercial printing, graphics, label & packaging, additive manufacturing, ... a team. + Excellent analytical skills. + Strong working knowledge of standard office software , including Microsoft Word and Excel. + Ability to work in a cleanroom… more
- Actalent (Pleasanton, CA)
- …Engineer, you will support design engineering development and reviews to ensure hardware device inclusion is sufficient to meet the intent of the systems sequence of ... operations. You will perform and lead software development in the generation of control systems databases,...to execute work to ensure high customer satisfaction and quality of delivery. + Excellent oral, written, and interpersonal… more
- SanDisk (Irvine, CA)
- …portfolio of products that are recognized globally for innovation, performance and quality . Sandisk has two facilities recognized by the World Economic Forum as ... various cryptography-based security features such as data encryption, Secure Boot, and Device Attestation. + Integrate these security protocols and features into the… more
- Teledyne (Poway, CA)
- …include aerospace and defense, factory automation, air and water quality environmental monitoring, electronics design and development, oceanographic research, ... edge design from concept through development and integration to its final application in the real world. **General Overview** The Electrical Engineer - Analog… more
- Cedars-Sinai (Los Angeles, CA)
- …of experience using 3D model software preferred + Knowledge of FDA Quality System Regulations, Medical Device Directives including ISO 13485, ISO 14971, and ... to be a part of breakthrough research?** Responsible for program/ application /product development supporting business objectives while providing expertise in all… more
- J&J Family of Companies (Santa Clara, CA)
- …portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary ... process development. The Staff Manufacturing Engineer also collaborates with Production, Quality , and R&D teams to support manufacturing operations and product… more
- Meta (Burlingame, CA)
- …Validation Engineer to join our medical devices compliance team, focusing on wearables and Software as a Medical Device (SaMD). This role will be responsible for ... and other innovative devices. Your expertise will be crucial in ensuring the quality and reliability of our products, particularly in areas such as:* Sensor… more
- J&J Family of Companies (Santa Clara, CA)
- …portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary ... to production. The Staff Manufacturing Engineer will work closely with production, quality , and R&D teams to support the company's manufacturing operations and… more