- Takeda Pharmaceuticals (Boston, MA)
- … and technologies. + Lead the following activities: + Combination products and device manufacturing process characterization. + Technology transfer to both ... contact for both internal and external device manufacturing and assembly sites to ensure process ...in industry best practices and emerging technologies for combination product and device manufacturing , with… more
- AbbVie (Irvine, CA)
- …role serves as Deputy Person Responsible for Regulatory Compliance for assigned Device Legal Manufacturer under EU MDR 2017/745, providing compliance subject matter ... management system compliance to external regulators, and leading continuous process improvement & globalization initiatives with other cross-functional AbbVie team… more
- Merck (West Point, PA)
- …Systems, Medical Device Regulations, Medical Devices, Medical Devices Design, Negotiation, Process Manufacturing , Product Design, Production Process ... Technical and Engineering Lead (Associate Director Equivalent)** _Our company's Device Product & Process Development...individual will be expected to apply his/her knowledge of product design and development; manufacturing process… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …IQ/OQ/PQ process , validation of assembly, processing, and analytical test equipment for device and drug product manufacturing . * **Competencies** : Cross ... Device Development is accountable for the technical development of Xeris' device and combination product programs to ensure commercialization strategy and… more
- Global Foundries (Essex Junction, VT)
- …devices characterization and development along with the development of the associated manufacturing process flows. + Demonstrated technical team leadership and ... GlobalFoundries is a leading full-service semiconductor foundry with a global manufacturing footprint spanning three continents. GlobalFoundries' Power Product … more
- Lilly (Indianapolis, IN)
- …or related field. + 5+ years of experience in pharmaceutical and/or medical device manufacturing or regulated industry. + Strong understanding of cGMPs and ... role where you'll be a pivotal force in our Device and Packaging Manufacturing division, supporting our...support technical expectations. Utilize in depth understanding of materials, process , automation, and product to improve. … more
- Lilly (Indianapolis, IN)
- …the step(s) of the product (s) and process (es) for each contract manufacturing relationship with focus on Device Assembling and Packaging. This role is a ... and the historic and potential failure modes of the process + Knowing the product process...fields. + 1+ year experience in pharmaceutical or medical device manufacturing ( process engineering experience… more
- AbbVie (North Chicago, IL)
- …and communicate safety issues. May contribute relevant clinical safety input to new product design teams as needed. The Medical Device Safety Physician is ... Review Safety Data Information for Instructions for Use (IFU) to ensure accurate device labeling New Product ( Device , Combo, IVD) Development Participates… more
- Lilly (Indianapolis, IN)
- …Description:** Join our elite team at Eli Lilly as we achieve drug product manufacturing and commercialization excellence. As the Associate Director of Technical ... **Additional Preferences and Information:** + Knowledge of cGMP requirements in medical device manufacturing , highly preferred. + Experience in device … more
- Texas Instruments (Dallas, TX)
- …optimization + MEMS process integration and fabrication evaluation and device characterization + Collaboration with fab/ manufacturing engineers to ensure ... capability of device + Failure root-cause investigation for device / process /reliability/yield/ product improvements + Work closely with product… more
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