- 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
- Fresenius Medical Center (Lawrence, MA)
- …+ Medical device or other safety critical device development + Familiarity with FDA and international software development guidelines and standards + Strong ... **PURPOSE AND SCOPE:** This Senior Staff Software Engineer will play a key role in...our internal Quality System, including specific requirements of GMPs, FDA QSR, IEC 62304, and ISO 9001 standards +… 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 ... Software Quality Assurance Engineer Job Description Responsibilities: *...Diagnostics (DNA sequencing) + SW Quality + V&V + FDA Docs Job Type This is a permanent position.… more
- Actalent (Columbia, MD)
- …ideally in a fast-growing or startup environment. + Regulatory experience in developing FDA -approved medical device software is a plus. Work Environment Small ... Job Title: Software LeadJob Description A rapidly expanding health technology...health technology company is seeking a dynamic and hands-on Software Lead to spearhead the development of innovative healthcare… 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
- 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
- Danaher Corporation (Vista, CA)
- …Intelligence and / or Image Analysis domain experience + Demonstrated experience with FDA submission process for medical device software The salary range for ... world's biggest health challenges. As the Project Manager, AI Software you will be responsible for utilizing the Agile...will be a part of the Artificial Intelligence (AI) Software Team and report directly to the Director Clinical… 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
- Terumo Medical Corporation (Somerset, NJ)
- …(KSA)** + Medical Device/Serialized product experience is required + Some familiarity with FDA CFR Part 11 Software Validation processes + Keen analytical skills ... + Keen sense of maturity, judgment and diligence required to: + Secure company's financial interests; and, + Avoid exposures to expensive delays and cost overruns. + Strong inter-personal and communication skills + Ability to cope with stress and continuously… more
- SAIC (Silver Spring, MD)
- **Description** SAIC is currently seeking a Senior Full-Stack Software Engineer to join our dynamic team supporting the Food and Drug Administration ( FDA ) HIVE ... (High-performance Integrated Virtual Environment) team . SAIC supports the FDA and its scientists and medical reviewers in Scientific Computing which includes,… more
- Abbott (Kansas City, MO)
- …working mothers, female executives, and scientists. **The Opportunity** The **Lead Software Quality Engineer** position within the Toxicology Business Unit, can be ... the quality and compliance of both product and non-product software throughout the software development lifecycle. The...quality. + Ensure compliance with regulatory standards (eg, DOT, FDA , ISO 13485, IEC 62304, as applicable). + Provides… more
- Hologic (Marlborough, MA)
- Senior Software Engineer, Cybersecurity Marlborough, MA, United States **Essential Duties & Responsibilities** + Performs cybersecurity engineering functions within ... criteria + Identify areas to improve our product to better align with FDA cybersecurity guidance and standards such as NIST Risk Management Framework, UL 2900,… more
- Abbott (Pleasanton, CA)
- …in working in an iterative (Agile, Scrum, Kanban) development process + Experience in Software risk-based design control processes such as FDA 62304 + Experience ... Opportunity** We are seeking talented, enthusiastic, and dependable **Senior Embedded Software Engineer** who will collaborate with our systems, human factors,… more
- Medtronic (Boston, MA)
- …**Nice to Have** + Expert knowledge of Medical Product verification, IEC-62304 and FDA guidance in a technical discipline, preferably software related (Computer ... role, you will join a world class team of mechanical, electrical and software engineers responsible for further development and enhancement of the globally launched… more