- Bristol Myers Squibb (Seattle, WA)
- …therapies for patients. **Key Responsibilities:** + Design, develop, and maintain high- quality software modules for cell therapy platforms, including automation, ... and maintain documentation, including specifications, flowcharts, and user manuals. + Ensure software quality through unit testing, code reviews, and adherence… more
- Abbott (Alameda, CA)
- …to junior team members. **Preferred Qualifications** + Knowledge of the principles of quality software engineering as described by software lifecycle ... software development, verification, and validation under guidance. + Adhere to FDA -compliant Design Control procedures for software development. + Demonstrate… more
- Abbott (Abbott Park, IL)
- …incident management processes. + Collaborate cross-functionally with laboratory personnel, IT, software quality assurance (SQA), and regulatory teams to ensure ... LIMS, software development, or laboratory informatics. + Strong knowledge of FDA regulations, Quality System Regulations (QSR), Medical Device Directive, ISO… more
- Medtronic (Minneapolis, MN)
- …and 14971. + Experience auditing Quality Systems to global requirements. + Quality System Lead Auditor certified. + Prior FDA or NB auditor experience. ... Compliance Audit Specialist focus will be primarily medical device software , product security, and risk management. We look for...Bachelor's degree with 7+ years of work experience in Quality or regulated industry OR Advanced degree with 5+… more
- Philips (San Diego, CA)
- …and manage performance requirements, while fostering a culture of continuous improvement and quality excellence. + Provides Software Quality leadership for ... (SiMD). Manages the development, oversight and execution of comprehensive software quality plans and associated risk management...You have a minimum of 8+ years' experience in FDA regulated, IEC 62304 medical device software … more
- Hologic (Newark, DE)
- …this role, you will leverage your expertise in design control, risk management, software development, and quality systems to ensure our medical devices, ... risk management, quality systems, and change management practices. + Support ** software design control** , including usability, risk management, and software … 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. ... Collaborate with cross-functional teams, including hardware engineers, product managers, and quality assurance, to define software requirements and deliver high-… more
- Globus Medical, Inc. (Audubon, PA)
- …we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the ... lives as quickly as possible. **Position Summary:** As a Group Manager of Software , you will be responsible for planning, managing and implementing all aspects of… more
- Globus Medical, Inc. (Methuen, MA)
- …we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the ... can resume their lives as quickly as possible. **Position Summary:** The Senior Software Engineer will be responsible for major software development modules for… more
- Medtronic (Boulder, CO)
- … testing strategies, including unit, integration, and automated testing to ensure high- quality code Participate in the design of software verification and ... and effects analysis Awareness of Medical Device standards and applicable FDA standards\Bachelor's degree in Computer Engineering, Software Engineering, Computer… more