- Merck & Co. (Rahway, NJ)
- … development activities (eg engineering design , engineering analysis and testing, medical device design controls, risk management, test method/fixture ... component of a combination product.Has broad knowledge of medical device development, design controls...and control strategy.Knowledge of US and global medical device and healthcare regulations, including FDA… more
- Merck & Co. (North Wales, PA)
- …devices or the device constituent of a combination product.Review and approve Design Control and Device Risk Management documentation for regulatory ... not limited to: Reporting to Senior Management of the Medical Device and Combination Product (MDCP) Quality...device functions and other personnel to ensure end-to-end Design Control principles are implemented effectively.Participate in… more
- Insmed Incorporated (Bridgewater, NJ)
- …of Insmed Person In Plant (PIP).Responsible for QA representation in Design Control Process for medical device products and combination products.Lead the ... Operating Procedures relating to areas of responsibility including product release, design control , etc.Act as company's representative during regulatory… more
- Skagit Regional Health (Mount Vernon, WA)
- …principals and statistical methods to identify target populations, analyze trends and design and evaluate prevention and control strategies. Leads the SRH ... practices. Provides expert clinical advice and leadership on infection control to ensure patients are protected from the risk...reported out, including the incidence of infections related to device use, as part of the on-going surveillance using… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of Distributor, Logistics and Demand Planning Operations (shipping, receiving, inventory control , customs clearance, supply / device management) Responsible to ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk...and manage relationships with external partners relevant to the design & implementation of clinical trials improvement/innovation projects for… more
- Lilly (Cambridge, MA)
- … design and testing. + Experience and understanding of the medical device lifecycle, design control , and general quality and regulatory requirements ... in mechanical or electro-mechanical engineering (MS preferred), with 5+ years of experience in medical device or combination product design and development +… more
- 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
- 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
- Olympus Corporation of the Americas (Westborough, MA)
- …Design History File and Technical Files post launch. He or she must fully understand medical device design control requirements and be able to ... to effectively work within a requirements management system. + Previous experience in design , development, and sustaining of Medical Devices. + Must have… more
- Integra LifeSciences (Cordova, TN)
- …projects. + Experienced in transferring and launching new products in manufacturing, medical device experience in design control is a plus. + Experience ... Design Control , and Process Validation guidelines applied to the Medical Device industry. + Knowledge of validation fundamentals (IQ/OQ/PQ), statistics… 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 (Maple Grove, MN)
- … design changes. + Excellent organizational, communication, and collaboration skills. + Solid medical device design control process and documentation ... + Read and make minor updates to schematics, layouts, BOM's, and other design outputs as needed utilizing Altium Designer. + Assist with updating Electrical lab… more
- Actalent (Maple Grove, MN)
- …changes Preferred Qualifications: * Excellent organizational, communication, and collaboration skills * Solid medical device design control process and ... * Read and make minor updates to schematics, layouts, BOM's, and other design outputs as needed utilizing Altium Designer * Assist with updating Electrical lab… more
- Amazon (Seattle, WA)
- …in the life As a 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
- 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
- Actalent (Plymouth, MN)
- …labels or other labeling materials ensuring compliance to all regulatory legal and medical requirements following the established design format labeling and UDI ... design systems: Loftware, Bartender, enLabel - Experience working with document control systems, especially Windchill - Design experience in the Adobe… 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
- Sanofi Group (Cambridge, MA)
- …The Quality Engineer- Device will drive new product development/life-cycle management design control activities by leading all cGMP compliance activities on ... early on in the product development process and through design control throughout the entire life-cycle of...and minimum of 2 years of experience in the medical device or combination products + Experience… more
- Merck (Rahway, NJ)
- … development activities (eg engineering design , engineering analysis and testing, medical device design controls, risk management, test method/fixture ... of a combination product. + Has broad knowledge of medical device development, design controls...control strategy. + Knowledge of US and global medical device and healthcare regulations, including FDA… more
