- Abbott (Alameda, CA)
- …products that meet budgetary objectives. + Implement approved design control procedures for software development in accordance with FDA guidelines. + Lead ... monitor their glucose levels with our new sensing technology. This Embedded Software Engineer works independently on the design, development, and maintenance of… more
- Actalent (Auburndale, MA)
- …TestRail). + Understanding of regulatory requirements and standards for medical device software (eg, FDA , ISO). + Strong analytical and problem-solving skills ... ** SOFTWARE TEST ENGINEERING OPPORTUNITY DEVELOPING NEXT-GEN SURGICAL ROBOTICS...DEVICE COMPANY** Job Description We are seeking a detail-oriented Software Test Engineer to join our team. You will… more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …external devices, ensuring robust communication and data handling. + Regulatory Compliance: Design software with FDA , QSR, and ISO quality system regulations in ... The Instrument Tech Transfer team develops new equipment, procedures, and test software for IVD medical device products that deliver rapid, high-impact, actionable… more
- Terumo Medical Corporation (Chicago, IL)
- …Align initiatives with PMO standards and regulatory requirements, including compliance for FDA Software as a Medical Device (SaMD) certification. Provide key ... to a broad range of constituents + Working knowledge of Epic and Cerner's software + Aptitude to identify and assimilate IT tools into the Care Pathway workflow… more
- Stryker (Portage, MI)
- …accordance with internal software development lifecycle requirements in compliance with FDA software development guidance. + Supports the research and design ... hardware using oscilloscopes, logic analyzers, and other hardware tools. ** Software Engineering/Computer Science Majors:** + Support development of procedures and… more
- Abbott (Casa Grande, AZ)
- …(GDP), and current Good Manufacturing Practices (cGMP). Familiarity with GAMP5 and FDA 's Computer Software Assurance initiatives are preferred. + Proficient with ... supervisor You'll be accountable for meeting our compliance standards including FDA , OSHA and Abbott policies and procedures. **Required Qualifications** +… more
- Medtronic (Mounds View, MN)
- …+ **Audits & Compliance Readiness** - Support internal and external audits (eg, FDA , Notified Body, MDSAP), ensuring software quality documentation and evidence ... a more connected, compassionate world. **A Day in the Life** Senior Software Quality Engineer Careers that Change Lives Transforming hypertension treatment, Renal… 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
- Zimmer Biomet (Englewood, CO)
- …for connected orthopedic or wearable devices + Familiarity with IEC 62304, ISO 13485, and FDA Part 11 compliance for software validation + Experience with EU MDR ... primary point of contact for product and project teams for Paragon 28 software applications and surgical system hardware + Maintain expert knowledge of appropriate… more
- Abbott (Pleasanton, CA)
- …5+ years' experience managing 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
- Hologic (Newark, DE)
- …+ Minimum of 8 years of experience in the following areas: + Designing software products in an FDA -regulated industry, following IEC 62304 and ISO 14971 ... Manager, Software Engineering Marlborough, MA, United States Newark, DE,...to lead and inspire? Join Hologic Inc. as our ** Software Engineering Manager** in Marlborough, MA or Newark, DE… more
- Philips (Cambridge, MA)
- …full ability to scale. **Your role:** + Design, develop, deploy, and release software applications in an FDA -regulated environment for a startup-like medical ... **R&D Application Software Engineer - C++ & Python** **(Cambridge, MA)**...Guided Therapies business. + Build, deploy, and maintain production software for ML and data pipelines. + Contribute to… more
- West Pharmaceutical Services (Cidra, PR)
- …standards + Maintain awareness of new technology trends, materials, and design/analytical software + Follow FDA , cGMP, ISO, and other applicable regulations ... and methods (eg milling, turning, grinding, eroding, etc.). + Familiar with cGMP, ISO, and FDA standards. + Able to be aware of all relevant SOPs as per Company… 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)
- … software Some familiarity with SOX and IRM compliance Some familiarity with FDA CFR Part 11 Software Validation processes Keen analytical skills Keen sense ... of maturity, judgment and diligence required to: i) Secure companys financial interests; and, ii) Avoid exposures to expensive delays and cost overruns. Strong inter-personal and communication skills Ability to cope with stress and continuously changing… more
- Kelly Services (Coral Springs, FL)
- …techniques (GC, TLC) + Familiarity with regulatory standards (USP, EP, ICH, FDA ) + Experience with analytical software (Empower, Chromeleon, ChemStation) + ... Strong documentation and problem-solving skills + Ability to work effectively in a team-oriented, results-driven environment As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related… more
- Abbott (Chicago, IL)
- …or related field + Medical Device experience + Experience working in an FDA -regulated business (eg validated software related to medical, pharmaceutical, or life ... with algorithm scientists, translating innovative concepts into reliable, production-ready software . + Implement robust CI/CD workflows for ML models, including… more
- Abbott (Sylmar, CA)
- …cybersecurity and data integrity risks. + Follow approved Design Control procedures for software development in accordance with FDA guidelines. + Contributes to ... Our location in **Sylmar, CA** , currently has an opportunity for a ** Software Quality Engineer II** **.** This position is responsible for executing and… more
- Abbott (Sylmar, CA)
- …years of Software Quality Engineering experience. + Detailed knowledge of FDA , GMP, IEEE 1012 and ISO 13485. Advanced computer skills, including tatistical/data ... heartbeats. This position is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for… more
- Wolters Kluwer (Chicago, IL)
- …EU MDR and FDA Class II medical device experience, focused on software as a medical device. **Other Knowledge, Skills, Abilities or Certifications:** + Working ... of a broad portfolio of on-market medical devices including Software as a Medical Device (SaMD) within the Health...US Quality System Regulation for SaMD regulated by the FDA , and EU MDR. + Perform design control activities… more