- Piper Companies (Wayne, PA)
- …in a biological science or related field Compensation for the Quality Control ManagerSalary Range: $90,000 - $95,000/yearBenefits: Medical , Dental, Vision, ... Piper Companies is currently seeking a Quality Control Manager for an opportunity in Wayne, Pennsylvania (PA), to join a contract research organization conducting… 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
- 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
- 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
- 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
- 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)
- …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
- Medtronic (Plymouth, MN)
- …* 4-7 years' experience working in Technical Project Management environment * Experience with medical device design control is desirable. * ... lasting impact. Help bring the next generation of life-changing medical technology to patients worldwide. Together, we can change...can thrive. Help bring the next generation of life-changing medical technology to patients worldwide. A Day in the… more
- Danaher Corporation (Stockton, CA)
- …manufacturing environment supporting software/hardware development projects. + Proven knowledge of design control processes, including design change, risk ... + Experience in a regulated industry, specifically knowledge of IVD and the Medical Device industry At Beckman Coulter Diagnostics, we believe in designing… 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
- 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)
- …+ Three plus years in design control , risk analysis and change control management for medical device or combination products + Demonstrated technical ... combination products globally. Experience in design controls, device risk management, medical device ,...medical devices or combination products + Experience in design controls, ISO 13485, deviation management, change control… 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
- Sanofi Group (Cambridge, MA)
- …Accountabilities:** The Quality Engineer will drive new product development/life-cycle management design control activities by leading all cGMP compliance ... early on in the product development process and through design control throughout the entire life-cycle of...+ Minimum of 2 years of experience in the medical device or combination products + Experience… 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
