- Abbott (Alameda, CA)
- …or embedded firmware under a disciplined product development process that meets FDA requirements. \# software **What** **you'll** **work on** + Works ... products that meet budgetary objectives. + Implement approved Design Control procedures for software development in accordance with FDA guidelines. + Lead … more
- Abbott (Alameda, CA)
- …or embedded firmware under a disciplined product development process that meets FDA requirements. \# software **What** **you'll** **work on** + Works ... products that meet budgetary objectives. + Implement approved Design Control procedures for software development in accordance with FDA guidelines. + Lead … more
- Abbott (Alameda, CA)
- … or embedded firmware under a disciplined product development process that meets FDA requirements. # software **What you'll work on** + Participate in the ... as assigned by management. + Implement approved Design Control procedures for software development in accordance with FDA guidelines. **Required Qualifications**… more
- Abbott (Pleasanton, CA)
- …reporting systems (eg, JIRA). + Experience with FMEA/risk management. + Knowledge of FDA regulations and software guidance, IEC 62304, IEEE 1012, ISO 13485, ... people in more than 160 countries. **Job Title** **Senior Quality Engineer, Software ** **About Abbott** Abbott is a global healthcare leader, creating breakthrough… more
- Actalent (Carlsbad, CA)
- … of Unknown Provenance (SOUP) tools or packages are up to date. + Own software -related FDA 510(k) submission documents. + Participate in the design and review of ... best practices. Essential Skills + Medical device experience + FDA Compliance + Risk management + Software ...+ FDA Compliance + Risk management + Software quality management + Design control + Compliance on… more
- Abbott (Alameda, CA)
- … or embedded firmware under a disciplined product development process that meets FDA requirements. + Contribute to software system designs including architecture ... monitor their glucose levels with our new sensing technology. The Senior Software Engineer, Device Driver will provide on-market product support, manufacturing … more
- Stryker (Portage, MI)
- …accordance with internal software development lifecycle requirements in compliance with FDA software development guidance. + Supports the research and design ... Stryker is seeking to hire an electrical engineering or software engineering co-op to support Orthopaedic Instrument's new product...best practices. What You Will Do The electrical or software engineering co-op will aid in the design, development,… more
- Medtronic (Newton, MA)
- …components. Experience with regulatory compliance and security protocols specific to medical software (eg, HIPAA, FDA regulations) is preferred but not required. ... Medtronic is seeking a highly skilled and experienced Senior Software Engineer to join our Affera Mapping and Ablation...Engineer to join our Affera Mapping and Ablation System Software Team. This role is pivotal in designing and… more
- WuXi AppTec (Cranbury, NJ)
- …offered. Require skills and knowledge inLC-MS/MS, HPLC/UPLC, Method Validation, BMV FDA guidance, Analyst software , GLP, Bioanalytical sampleanalysis. **Need ... Bioanalytical sample analysis, calibration and troubleshooting of LC-MS/MS,HPLC/UPLCfollowing BMV FDA guideline; Analyze and interpret Bioanalytical project data for… more
- Actalent (San Diego, CA)
- …daily scrum. * Participating in root cause analysis. * Creating and updating software documents under FDA guidelines. Skills python, robot framework, automated ... API testing, SQL database, google cloud, FDA compliance, scrum, docker, kubernetes, CI/CD, selenium Additional Skills & Qualifications 5-7 years' experience required… more
- Interior, US Fish and Wildlife Service (Bozeman, MT)
- …source data. Conducts statistical analysis of data using commercially available software . Develops FDA -accepted Study Protocols that thoroughly describe all ... fulfilled in compliance with current regulations of the US Food and Drug Administration ( FDA ). All activities of the AADAP Branch are focused on providing public and… more
- Abbott (Pleasanton, CA)
- …3+ years experience leading a team of technical/quality professionals. + Knowledge of FDA regulations and guidance, ISO 13485, Software Standards (eg, IEC ... Heart Failure business includes implantable devices and peripheral systems with software /firmware, Cloud-based Patient Care Networks, and mobile applications to help… more
- Abbott (Plymouth, MN)
- …integration, verification and software system testing. + Experience in non-product software validation compliant with FDA 21 CFR Part 820, EU-MDR ... structural heart disease. **What You'll Work On** As the Software Test Engineer, you'll have the chance to provide...of structural heart disease. The incumbent will lead the software test workstream across a product ecosystem involving multiple… more
- J&J Family of Companies (Santa Clara, CA)
- …Regulatory Knowledge: Familiarity with medical device regulations and standards (eg, ISO, FDA ) to ensure that software solutions meet compliance requirements. + ... designed for easy maintenance and support, addressing both hardware and software needs effectively. + Oversee the strategic development and continuous improvement… more
- Insight Global (Marlborough, MA)
- …In office work of 50% or greater is preferred. Experience working in an FDA regulated environment is a plus Software engineering skills are desired. Knowledge ... the our client's digital cytology products. These products are FDA approved medical laboratory devices which process samples and...stored, viewed, and archived. This position is for a software engineer who will be tasked with reviewing the… more
- Terumo Medical Corporation (Somerset, NJ)
- …Skills and Abilities (KSA)** + Familiar with SOX and IRM compliance + Familiar with FDA CFR Part 11 Software Validation processes + Keen analytical skills + Keen ... of business and technology, this role will support the development of software modeling and user interfaces to provide visual manufacturing execution to… more
- MicroVention, Inc. (Aliso Viejo, CA)
- …Windchill environment in a Solution Architect role. 4. General knowledge of ISO, FDA , and other auditable software and data management compliance requirements. ... management and executives. + Provide guidance and support for software user acceptance testing and software validation...support for software user acceptance testing and software validation efforts through the creation of test protocols,… more
- Terumo Medical Corporation (Somerset, NJ)
- … software + Some familiarity with SOX and IRM compliance + Some familiarity with FDA CFR Part 11 Software Validation processes + Keen analytical skills + Keen ... proper design, development and testing. **Knowledge, Skills and Abilities (KSA)** + Software : Strong knowledge of SAP Suite of Products and their latest versions… more
- Terumo Medical Corporation (Somerset, NJ)
- …to SAP software + Familiarity with SOX and IRM compliance as well as FDA CFR Part 11 software validation processes + Ability to perform accurately under the ... pressure of time constraints. + Understanding of overall ERP systems and standard operating procedures. + Must be trustworthy and professional and maintain confidentiality in all situations. **Qualifications/ Background Experiences** + Bachelor's degree or… more
- J&J Family of Companies (Palm Beach Gardens, FL)
- …of ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1, MDD/MDR, and IEC 62304, FDA 's General Principles of Software validation. + Passion for development of new ... technologies, including the ability to apply design controls to new technologies. Other: + This position may require up to 10% domestic and international travel. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified… more