- MicroVention, Inc. (Aliso Viejo, CA)
- …risk analysis, design verification, and design validation. 2. Strong knowledge of medical device design control process. 3. Ability to understand ... quality issues. Work with R&D and Manufacturing to lead design control activities for the implementation of...3. Demonstrated command and knowledge of FDA and ISO medical device quality system requirements. 4. Proven… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- … medical device packaging design systems + Proven experience following medical device design control Preferred + Proven expertise in finite ... packaging design for Class II and III medical device , pharmaceutical and combination products. +... validation methodology + Packaging systems, medical device class II and III, design verification… more
- Organon & Co. (Plymouth Meeting, PA)
- …Ops, Product Development groups, Regulatory Affairs, Procurement and suppliers. Knowledge of design control , medical device , combination products, ... **Job Description** **The Position** The Senior Specialist Medical Device and Combination Product (MDCP)...project teams and other technical staff in regard to design control , risk management, product development, and… more
- MicroVention, Inc. (Aliso Viejo, CA)
- …analysis, design verification, and design validation. 2. Strong knowledge of the medical device design control process. 3. Ability to understand ... **Job Description:** Work with R&D and Manufacturing to lead design control activities for the development and...3. Demonstrated command and knowledge of FDA and ISO medical device quality system requirements (ISO 14971,… more
- J&J Family of Companies (Raritan, NJ)
- …fast-paced and innovative environment 2) pushing pipelines towards market launch in a structured medical device design control environment. This position ... **.** **Transition the advanced visualization technology from feasibility stage into medical device product development.** **.** **Work with external… more
- Medtronic (Minneapolis, MN)
- …minimum of 8 years of relevant experience. + Hardware and/or software medical device project management or development experience + Design Control ; ISO ... audit findings. + Collaborate cross functionally with other CRDN functions on design control related initiatives. + Collaborate across OUs on shared process and… more
- Integra LifeSciences (Columbia, MD)
- …projects. + Experienced in transferring and launching new products in manufacturing, medical device experience in design control is a plus. + Lean Six ... guidance of engineering leadership within the constraints of domestic and foreign Medical Device Regulations. The employee will investigate, determine root… more
- Actalent (Versailles, OH)
- …, automotive, aerospace industry experience COMPETENCY/SKILL REQUIREMENTS: * Design experience within a specific engineering discipline (software, firmware, ... to meet the needs of their users. They will support planning and executing design verification and validation to verify design requirements are met. Systems… more
- Amazon (Seattle, WA)
- …the life As a Senior Design Technologist working on the next generations of device user experiences, no two days are the same. You might start by reviewing a ... Description As part of Amazon's Devices and Services Design Group (DDG), the Futures Design ...engineering best practices, including coding standards, code reviews, source control , CI/CD, testing, and operational excellence - Experience with… more
- Fresenius Medical Center (Ogden, UT)
- …in Ogden, Utah.** **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + Ensure that all design control deliverables comply with applicable regulatory requirements and ... design and development documentation for project and for design control activities. + Support Product Center/Project...Support Product Center/Project Manager to get part needed to Medical Device Compliance and Regulatory Affairs to… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …is responsible for using their broad technical expertise, leadership skills, and medical device development process knowledge to drive and support innovation ... work with cross-functional engineers to progress the technology for medical device infusion systems (with mechanical parts,...takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of… more
- Merck (Rahway, NJ)
- … development activities (eg engineering design , engineering analysis and testing, medical device design controls, risk management, test method/fixture ... a combination product commercial image consisting of a delivery device component/constituent (ie, predesign control ). This will...product and process development. + Has broad knowledge of medical device development, design controls… more
- Merck (Rahway, NJ)
- … development activities (eg engineering design , engineering analysis and testing, medical device design controls, risk management, test method/fixture ... development including regulatory submission and approval processes. + Has broad knowledge of medical device development, design controls and risk management… more
- Kelly Services (Warren, NJ)
- …Overview:** The **Quality Engineer** is the subject matter expert for Software as a medical device SAMD and/or software as an accessory/component to a medical ... changing needs and requirements. + Ensure that upgrades to medical device reagents and software are made...editing and review of impact and risk assessments for design , process, and risk control activities. Ensure… more
- ICU Medical (San Diego, CA)
- …Device Software position manages the Quality activities related to ICU Medical Device Software Development, Testing, and Release, within Device ... the organization's expert within a particular discipline .Working knowledge of Medical Device Regulations .Quality compliance, audit, and investigation skills… more
- Catalent Pharma Solutions (Morrisville, NC)
- …requirements and expectations. The Associate Director will also ensure all aspects of Design Controls for medical device /combination products are implemented ... Write, revise, and review SOPs for approval associated with design control + Support new combination product...design controls + Support FMEA associated with the design and production of medical device… more
- Kelly Services (Middletown, VA)
- …university and 5+ years of relevant experience or in the pharmaceutical, medical device , or in-vitro diagnostics industry with progressively increasing ... Associate degree and 10+ years of relevant experience in the pharmaceutical, medical device , or in-vitro diagnostics industry with progressively increasing… more
- Merck (West Point, PA)
- …and transfer of design to production sites. Using the frame works of design controls, medical device risk management, and usability engineering, the ... to audit or regulatory comments. **Principal Responsibilities and Requirements** + Authors Design Control documents and leads other individuals on supporting… more
- Battelle Memorial Institute (Columbus, OH)
- …Columbus, OH** . Responsible for the general management of a $25-to-$30 million-dollar Medical Device and Drug Delivery business line and accountable for ... sustains an active client base. Maintain and develop a workforce of leading tier medical device development professionals. This Medical Devices Business Line… more
- Gilead Sciences, Inc. (Foster City, CA)
- …characterization studies, selecting and specifying manufacturing equipment, and authoring/reviewing design control documents. + Manage commercial change controls ... at contract manufacturing organizations. + Deep experience and knowledge in medical device development and commercialization, process validation, and related… more