- Merck (Rahway, NJ)
- **Job Description** **Job Description** As a Design Control and Risk Management Data Manager, you are a key member of the Device Development Team. Your ... responsibilities include the following:** + Partner with the Design Control and Risk Management leads to determine the data relationships and mapping.… more
- Danaher Corporation (Coralville, IA)
- … process improvements and act as resource for colleagues in explaining design control and risk management concepts and requirements; may include coaching ... and developing proficiency in the use of design control and risk management principals/ processes to establish the best approaches to problems. The… more
- Hologic (Newark, DE)
- …Engineer** to join our dynamic team. In this role, you will leverage your expertise in design control , risk management , quality systems, and change ... to the design and maintenance of our medical devices through rigorous design control , risk management , quality systems, and change management … more
- J&J Family of Companies (Palm Beach Gardens, FL)
- …**Required:** + A minimum of three (3) years of relevant experience with a focus on design control , risk management , and verification & validation. + A ... user needs, design & development plans, usability, requirements, design documentation, risk management file, and verification & validation artifacts) to… more
- Fresenius Medical Center (Lawrence, MA)
- …Assist in the development and maintenance of company procedures for design control , change managements, risk management , process validation and related ... Master Record (DMR) reviews meetings and fully understand the design control process and Quality Engineering. Utilize... design verification, validation, specification and procedure development, risk management , and design review.… more
- Bausch + Lomb (St. Louis, MO)
- …System Engineer further provides system-level oversight and high-level management of all design control , risk management , and usability engineering ... used throughout the product life cycle to manage design control (DHF/DMR), risk management , and usability engineering documents and specifications. *… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …other relevant tasks. PM I/II is competent in design control , change control , and risk management as they relate to medical device development and/or ... + Manages and tracks project or program budget. + Utilizes knowledge of BioFire products, design control , risk management and change control to draft… more
- AbbVie (North Chicago, IL)
- …with AbbVie's software lifecycle policies and procedures. * Perform design control and risk management activities (including cybersecurity risk ... System * Partner with technical teams to ensure design control documentation ( Risk Management , Traceability/Linkages) & design change control… more
- Edwards Lifesciences (Irvine, CA)
- …leadership for successful new product development projects by applying design control and risk management principles to positively influence new ... to commercialization (Class III preferred). + Experience with Risk Management and Design Control + Working knowledge of the Domestic and International… more
- Edwards Lifesciences (Irvine, CA)
- …Quality Engineering input to THV commercialized product projects including application of design control and risk management + Be a subject matter expert ... THV products. This includes support of product configuration changes, providing design control expertise for manufacturing improvements, leading investigations… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …+ COMSOL + Minitab Knowledge, Skills, and Abilities + Advanced knowledge of BioFire products, design control , risk management , and change control . ... generally considered within the realm of instrument and fixture design . They are expected to communicate well with other...+ Communicate project status to team members and to management . + Present project-related updates to large groups and… more
- WSP USA (Los Angeles, CA)
- …PMO business + Develop Project Management Plans to include Program Controls, Document Control , Design Management , Risk Management , Safety ... **This Opportunity** Join our growing Program Management Team that meets our client's objectives and...+ Bachelor's degree in engineering or similar + Extensive Design -Build project delivery experience as a Program Manager or… more
- Lilly (Indianapolis, IN)
- … design verification testing, and human factors) + Experience with design control processes, including risk management and failure modes & effects ... to those who need them, improve the understanding and management of disease, and give back to our communities...to market of patient centered designs + Coordinate device risk assessments and design control … more
- Bayer (Whippany, NJ)
- …of medical device regulations and industry standards globally for design control , device risk management , and post-market surveillance throughout the ... is an expert who provides safety oversight and content contributions to design control , clinical evaluations, vigilance reporting to authorities and… more
- Teleflex (Maple Grove, MN)
- …matter expertise and technical leadership in best-practice quality, reliability, design control , statistics, and risk management tools and techniques ... challenge ofemergency vascular access, and + QuikClot(R) and QuickClot Control +(R) hemostatic devices, used by hospitals, EMS, and the...our products' life cycle. * Support the development of risk management documentation such as risk… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …+ Deep understanding of panel development process + Understanding and demonstrated experience with design control , risk management , and change control ... The Program Director leads the program management and lifecycle management of the programs that compose the BioFire IVD Panels portfolio including all aspects of… more
- Catalent Pharma Solutions (Kansas City, MO)
- …Inventor, CAD, Track wise, Documentum highly preferred + Knowledge regarding design control , documentation, risk management and processes such as FMEA, ... safety of every patient, consumer, and Catalent employee.** **The Role:** + **Maintenance Management ** : Leading the life cycle management and maintenance of… more
- Teleflex (Morrisville, NC)
- …* Proven expertise in global aspects of regulatory, including compliance, design control , and risk management activities. * Strong regulatory affairs ... agencies / Notified Bodies to support product life cycle management , including FDA for Class II and III Pre-Submission...as needed. * Participate in and ensure compliance with design controls and review design documentation to… more
- Vera Therapeutics (Brisbane, CA)
- …* Participate in the development, and review and approve of product documentation, including design control , risk management , and validation protocols. * ... 820, ISO 13485, and EU MDR. * Familiar with combination product lifecycle management from initial design phase to commercialization. * Experience with biological… more
- Teleflex (Plymouth, MN)
- …a team environment. * ASQ Certified Quality Auditor highly desired * Design Control and Risk Management experience desired. \#LI-NR1 _At Teleflex, we ... apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering,… more