- Cepheid (Miami, FL)
- …responsible for leading the development of best in class user experiences for our medical diagnostic testing device products. As a UI Architect you will ... front-end architectures. Establish best practices for component-based architecture, state management , and performance optimization. Ensure seamless integration of UI… more
- Beckman Coulter Life Sciences (Indianapolis, IN)
- …experience in product development, manufacturing and / or quality systems (ISO 9001), medical device (ISO 13485), pharmaceutical, related life sciences or other ... conformance with particular focus on Design Controls, Document Controls, Risk Management (per ISO 14971), Production, Service Controls. Assuring compliant process… more
- HCA Healthcare (Nashville, TN)
- …Do you want to join an organization that invests in you as a Director, Sourcing Medical Device Management ? At HealthTrust, you come first. HCA Healthcare has ... the opportunity to make a difference. We are looking for a dedicated Director Sourcing Medical Device Management like you to be a part of our team. Job… more
- Merck (Rahway, NJ)
- …Decision Making, Dosage Forms, GMP Compliance, Inspection Readiness, Management Process, Medical Device Management , Medical Devices, Operational ... **Job Description** **Raw Materials & Medical Device Director, Small Molecule Analytical...for proactive resourcing planning, risk assessment strategies, and budget management as necessary. **Primary Responsibilities** : + Leading a… more
- Henry Ford Health System (Detroit, MI)
- …security in healthcare environments. This includes overseeing medical device discovery platforms, network segmentation initiatives, vulnerability management ... Build and nurture relationships with clinical stakeholders and department leaders. Medical Device Security Program Management : + Develop and oversee… more
- Albany Medical Center (Albany, NY)
- …improvements in processes, procedures, and operations that improve the function of a medical device management program. + Demonstrated support experience and ... the symptom of the issue + Provide support with medical device troubleshooting, configuration and diagnostic tools...project management of basic to moderately complex medical device related projects + Incorporates proper… more
- US Tech Solutions (San Bruno, CA)
- …with Quality System procedures, utilizing expertise in the medical device product development life-cycle, Risk Management , Design/Process Verification, and ... system issues. **Mandatory:** + 5+ years of experience in program management . + Experience in Medical Device Manufacturing or Software as a Medical… more
- Lilly (Indianapolis, IN)
- …+ 5+ years of experience in asset/project delivery and/or medical device development & commercialization + Demonstrated Project Management skills + ... to those who need them, improve the understanding and management of disease, and give back to our communities...leadership for Commercialization Global Program Managers (GPM's) who lead medical device and drug/ device combination… more
- Bausch Health (Bothell, WA)
- …regulatory required + Must have a solid understanding of Change Management /Life Cycle Management of medical device products along with the impact of ... written and communication skills. + Should have experience authoring complete 510(k) submissions, Medical Device license applications (Class II or above), EU MDR… more
- Terumo Neuro (Aliso Viejo, CA)
- …process enhancements. + Stay current with industry trends, regulations, and best practices in medical device project management , and apply them to improve ... 2. Minimum of eight (8) years of relevant professional experience in project management within the medical device industry. 3. Minimum of two (2) years of… more
- Hologic (Marlborough, MA)
- …systems and change management . **Essential Duties and Responsibilities:** + ** Medical Device Quality Assurance:** Provide comprehensive support to ensure the ... Devices-820 Quality System Regulation, especially Design Control requirements, ISO 13485 Medical Device Quality management System, ISO 14971:2019, Risk… more
- Amgen (Thousand Oaks, CA)
- …of the following standards and regulations: Quality System Regulation - 21CFR820; Quality Management System for medical device /component manufacturers - ISO ... Engineer in our Combination Product Development and Lifecycle management group. The Device Engineer will participate...for Medical Devices - ISO 14971; EU Medical Device Regulation - 2017/745 **What you… more
- Philips (Colorado Springs, CO)
- …system solution software; the quality and compliance of medical device labeling; internal and external database management ; validation activities (software ... **Labelling Systems Quality Engineer I - Medical Device (Colorado Springs, CO)** You...departmental Standard Operating Procedures (SOPs). + Ensuring timely change management of labeling and Instructions For Use (IFUs), working… more
- Abbott (Maple Grove, MN)
- …Registration support + Ad and Promotional Material - Regulatory Review + EU and US medical device compliance + Project management skills - organize and host ... for diversity, working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that are faster, more… more
- Medtronic (Mounds View, MN)
- …: + Demonstrated program/project management experience, + Hardware and/or software medical device program management experience + PMP certification; ... world. **A Day in the Life** Senior Principal Project Management Specialist Careers That Change Lives In this exciting...drive healthcare forward and remain a global leader in medical technology and solutions. At Medtronic, we bring bold… more
- Dartmouth Health (Lebanon, NH)
- …(6) years of applicable Biomedical/Clinical Engineering, or HTM experience required. * Prior medical device management experience required. * Must have ... Management , Medical Equipment hazard recalls, incident investigations, and medical device reporting. * Performs other duties as required or assigned.… more
- System One (Malvern, PA)
- …sciences related field. + RAC certification. + 15+ years Regulatory Affairs in medical device field with management responsibilities. + Strong understanding ... submissions. + Manage and maintain ongoing submissions such as annual reports, medical device facility registrations and device listings. + Support efforts… more
- Hologic (Marlborough, MA)
- …quality data evaluation. + Awareness of industry advancements and best practices in medical device quality management . **Skills** + Exceptional leadership ... innovation, and customer success, apply today! **Knowledge** + Strong understanding of Medical Device Regulations, including FDA requirements (21 CFR Part 820,… more
- J&J Family of Companies (Cincinnati, OH)
- …and experience in clinical research, quality regulatory compliance, adverse event reporting, medical device risk management process, and common statistical ... Reports (SSCP) for Ethicon Endo-Surgery within J&J Global R&D Medical Device sector. **DUTIES & RESPONSIBILITIES** Under...for communicating business related issues or opportunities to next management level. + For those who supervise or manage… more
- Medtronic (Lafayette, CO)
- …Plans, manages and implements aspects of the Surgical Operating Unit's (SOU) Post-Market Risk Management of medical device products or software systems. * ... 2 years of managerial experience. SPECIALIZED SKILLS OR EXPERIENCE * Risk Management experience in the medical device industry * Risk Management File… more
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