- Beckman Coulter Diagnostics (Miami, FL)
- …Master's degree in field with 0+ years' experienceExperience working in medical device manufacturing, pharmaceutical, or other regulated environment.Demonstrate ... , value stream mapping, standard work ) /Lean/Kaizen/6-sigma, Problem Solving Process (PSP) Risk management , process validation, design of experiments, and design… more
- Beckman Coulter Life Sciences (Miami, FL)
- …and service conformance with particular focus on Design Controls, Document Controls, Risk Management (per ISO 14971), Production, Service Controls. Assuring ... experience in product development, manufacturing and / or quality systems (ISO 9001), medical device (ISO 13485), pharmaceutical, related life sciences or other… more
- Cytiva (Miami, FL)
- …control and sterility assurance within the pharmaceutical, biotechnology, or medical device industries.In-depth knowledge of regulatory requirements and ... assurance protocols as directed by Contamination Control and Sterility Assurance management .This position reports to the Sr. QA Manager Contamination Control and… more
- Merck (Wilson, NC)
- …ensure compliant implementation and robust application at the site. Experience in design controls, device risk management , medical device , ... to our Company strategy and business goals + Utilize device risk management tools to...design control, risk analysis and change control management for medical device or… more
- Merck (Rahway, NJ)
- …of medical devices and combination products globally. * Experience in design controls, device risk management , medical device , complex ... design control, risk analysis and change control management for medical device or...Risk Management , Materials Science, Mechanical Engineering, Medical Device Management , Medical… more
- Amgen (Cambridge, MA)
- … - ISO 13485; Risk Management - ISO 14971; EU Medical Device requirements - Council Directive 93/42/EECStrong background in documenting requirements and ... transform the lives of patients while transforming your career. Engineer I - Medical Device Design Control Documentation Specialist **What you will do** Let's… more
- AbbVie (North Chicago, IL)
- …for this position + 0-5 years of experience in drug risk management and/or medical device / combination product vigilance (safety signal detection, ... device development process in a global medical device company and preparation risk management plans, aggregate reports and company core safety… more
- Kestra Medical Technologies, Inc (Kirkland, WA)
- …+ Deep knowledge of embedded systems and software architecture, safety risk management , and medical device quality considerations + Commitment to extreme ... years of experience in the external and internal cardiac medical device markets. The company was founded...technologies, trends and clinical applications in the Cardiac Rhythm Management (CRM) industry COMPETENCIES + Ability to be a… more
- Globus Medical, Inc. (Methuen, MA)
- …Python, programming experience preferred. + Familiarity with design control processes, risk management , and medical device regulations (FDA 21 CFR Part ... the verification of complex electro-mechanical hardware systems to ensure compliance with medical device standards and design requirements. You'll work closely… more
- Edwards Lifesciences (Irvine, CA)
- …degree in engineering or scientific field with at least 4 years of experience in medical device risk management ; or Master's degree in engineering ... or scientific field with at least 3 years of experience in medical device risk management . + Strong knowledge of ISO 14971, ISO 13485, 21 CFR Part 820,… more
- Teleflex (Morrisville, NC)
- …investigation teams. Understands the fundamentals of root cause investigation, risk management , and medical device Quality Management Systems ... BS Degree in Engineering (or related technical field) + 0-2 years related ( medical device preferred) experience **Specialized Skills / Other Requirements** +… more
- Terumo Medical Corporation (Somerset, NJ)
- …+ Bachelor's Degree and a minimum of 10+ years of Enterprise Risk Management or related experience required, preferably in medical device ; or equivalent ... Director, Enterprise Risk Management Date: May 27, 2025...of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in… more
- Amgen (Cambridge, MA)
- …Regulation - 21CFR820, Risk Management - ISO 14971, EU Medical Device requirements - Council Directive 93/42/EEC. + Strong understanding and experience ... such as Quality System Regulation - 21CFR820, Risk Management - ISO 14971, and EU Medical Device requirements - Council Directive 93/42/EEC. + Strong… more
- Amgen (Cambridge, MA)
- … (ISO 13485); + Risk Management (ISO 14971); + EU Medical Device requirements (Council Directive 93/42/EEC); + Medical Electrical Equipment (EN ... various global manufacturing sites. This role requires a deep understanding of medical device design, manufacturing processes, and regulatory requirements. Key… more
- Rush University Medical Center (Chicago, IL)
- …equipment uptime, standardization, and interoperability across RUSH facilities. Lead risk management efforts related to medical device security, recalls, ... system. Knowledge of cybersecurity best practices for biomedical equipment and medical device integration. **Physical Demands:** Ability to work within… 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 ... you have 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.… more
- Sanofi Group (Cambridge, MA)
- … report) according to ISO 14971 and TIR 57 + Plan, prepare and perform risk management activities for medical devices according to project phases following ... Our team has released an FDA certified class II medical device titration application. We are gearing...and quality system related activities. + Relevant experience in risk management for medical devices.… more
- Organon & Co. (Jersey City, NJ)
- …+ Contribute towards the development of Design History Files. + Support development of Device Risk Management as needed. + Participate on Organon teams ... devices. + Extensive knowledge of applicable medical device regulations (21CFR820, MDD, ISO 13485:2016), Risk ... device regulations (21CFR820, MDD, ISO 13485:2016), Risk Management Experience (ISO 14971:2012). + Demonstrate… more
- LSI Solutions (Victor, NY)
- …in 1986, located in beautiful Victor, New York, is a dynamic and growing medical device company with over 500 employees dedicated to advancing minimally invasive ... passionate people looking to make a difference in the medical device industry. By joining LSI SOLUTIONS(R)...ISO 14971 ( Risk Analysis) + Knowledge of risk management and analysis preferred. + Knowledge… more
- Henry Ford Health System (Detroit, MI)
- …security in healthcare environments. This includes overseeing medical device discovery platforms, network segmentation initiatives, vulnerability management ... and nurture relationships with clinical stakeholders and department leaders. Medical Device Security Program Management :... Management and Compliance: + Develop comprehensive risk assessment frameworks for medical devices and… more
