- Philips (Latham, NY)
- …fairer future for all. **In this role you have the opportunity to** The Quality Engineer provides independent oversight of the design input process, design ... and performance in the field to ensure that all design requirements are effectively met. The Quality Engineer also provides analytics to the Business on the… more
- Danaher Corporation (Sacramento, CA)
- …with diagnostic tools that address the world's biggest health challenges. The Staff Design Quality Assurance role for Beckman Coulter Diagnostics is responsible ... Assurance) team and report to the Manager of Design Quality Assurance responsible for Diagnostic Software...a regulated industry, specifically knowledge of IVD and the Medical Device industry The salary range OR… more
- Takeda Pharmaceuticals (Boston, MA)
- …authoring and meetings with global health authorities + Reviews and approves medical device development design control documentation, including technology ... first time + Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations, with emphasis on Design Controls, and… 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 ...to hear from you. Key job responsibilities - Build high- quality , functional prototypes that convey, prove, and advance the… more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- …efficient communication to management with decision-making responsibilities related to the quality of design control of our combination products. Essential ... Description: Drug Device Combination Product Manager is a position within the Global Quality Management department. This position is a Corporate Quality … more
- Bristol Myers Squibb (Princeton, NJ)
- …for medical devices & combination products by drawing on experience w/ medical device quality system regulations, including ISO 13485, 21CFR 820, ... device quality group, & product quality group for medical device ...records & ICSR case processing, respectively. Review, understand, & design safety reporting requirements for medical devices… more
- Philips (Bothell, WA)
- …a minimum of 10 years' experience working in FDA regulated medical device quality , with a focus in Design Quality Engineering in support of the ... Philips Ultrasound Quality Organization, the Head of Design Quality Engineering will lead and develop... Leader-Ultrasound, you will partner with R&D, Product Management, Medical Safety & Clinical and other key functions to… more
- Merck (Wilson, NC)
- …product development or manufacturing operations. + Experience in design controls, device risk management, medical device , combination products, prefilled ... hosting audits and addressing audit findings. **Delivery:** + Apply device risk management and design control principles...with injection molding and working with medical device suppliers. + Experience leading Quality Management… more
- Danaher Corporation (San Diego, CA)
- …5 years of quality assurance experience in a production environment in the Medical Device , Pharmaceutical or Life Science industry. + Prefer minimum of 5 ... site are compliant with Design Controls and the relevant elements of the Quality System Regulations and ISO requirements. + Lead the Quality Assurance and … more
- US Tech Solutions (San Bruno, CA)
- …and align with Quality System procedures, utilizing expertise in the medical device product development life-cycle, Risk Management, Design /Process ... to release, manage project schedules, mitigate risks, handle the Design History File, and align with stakeholders. + Collaborate... Manufacturing or Software as a Medical Device (SaMD). + Experience with Quality Management… more
- Merck (Rahway, NJ)
- … development activities (eg engineering design , engineering analysis and testing, medical device design controls, risk management, test method/fixture ... complexity programs they are selected lead to ensure high quality products and robust manufacturing processes. This position interacts...of a combination product. + Has broad knowledge of medical device development, design controls… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …our team. It's a great time to be a part of ZOLL!Job SummaryThe Medical Device Cybersecurity Technical Project Manager combines technical expertise with project ... management skills to drive cybersecurity initiatives across a portfolio of medical device products. This role involves hands-on work as well as overseeing the… more
- Sanofi Group (Bridgewater, NJ)
- …be responsible to lead the design , development, and implementation of connected medical device technologies and ensuring they meet the specific needs of the ... representatives from the core device platforms and device manufacturing sites, Digital, Global Quality , GRA...work experience in the area of connected & digital medical device technologies or equivalent. + Working… more
- Vera Therapeutics (Brisbane, CA)
- …biological drug products is a plus. * In-depth knowledge of current FDA and EU medical device regulations and quality systems. * Experience with human ... will possess a deep understanding of drug delivery systems, medical device regulations, and a proven track...Provide technical leadership and expertise in drug delivery technologies, device design , and manufacturing processes. * Manage… more
- Global Foundries (Malta, NY)
- …to improve efficiencies and accuracy. + Strong collaboration with Fab and design teams to understand device specifications and performance requirements of ... organization + Coordinate cross-functional teams ( Device Model Characterization Lab/ PDK/ Device / Process Integration/ Design Manual/ Test chip Design … more
- Global Foundries (UT)
- …emphasis on innovative methodology enhancement and lesson learned. + Collaborate with Fab, device and design teams to understand device specifications and ... + Coordinate cross-functional teams ( Device Model Characterization Lab/ PDK/ Device / Process Integration/ Device Development/ Design Manual/ Test… more
- Merck (Rahway, NJ)
- …leadership or management role. + Demonstrated technical leadership in Technology Transfer and Design Transfer for medical device and combination product ... new products. **Technical Expertise:** + Utilize extensive experience in design controls, device transfer, control strategies ...preferred. + Minimum of 10 years of experience in medical device or combination product engineering, with… more
- Battelle Memorial Institute (Columbus, OH)
- …under a registered QS and under FDA Design Controls. + Experience in medical device design and testing for regulatory/ compliance (ie IEC 60601) ... welcome all qualified individuals to apply. **Job Summary** The Medical Device Solution team is seeking a...field. + Background in product development process, operating under Quality System and Design Controls + US… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Monitors regulatory landscape in US to maintain contemporary knowledge of global medical device and combination product regulations, standards, and guidance + ... business issues to ensure regulatory filings are of high quality and right first time. + Maintain up-to-date knowledge...preferred + 10+ years of pharmaceutical Regulatory CMC and Medical Device experience, including experience as a… more
- Amazon (Seattle, WA)
- …systems, workflows for Al-generated imagery, and lifestyle renders that scale in volume and quality . 3D device and lifestyle renderings play a critical role in ... project owners * Work with producers and designers on design for concepts and execution * Adhere to Amazon...that understand Amazon customers and how to deliver high quality , photo-realistic device renders at scale. We… more