- Cytiva (Miami, FL)
- …and CAPA initiatives, ensuring timely resolution of nonconformances to maintain product quality and customer satisfaction; overseeing manufacturing validation ... and approve change control documentation (ECOs) to mitigate risks to product quality.Conduct investigations into manufacturing and design-related failures,… more
- Raytheon (Mckinney, TX)
- …career field that specializes in designing custom mechanical solutions to support manufacturing , assembly, inspection, and test throughout the product lifecycle. ... procuring and integrating assembly Tooling into a highly complex manufacturing environment. Tool Engineers oversee projects from development to implementation… more
- Beckman Coulter Life Sciences (Indianapolis, IN)
- …Controls, Risk Management (per ISO 14971), Production, Service Controls. Assuring compliant process and product documentation, inclusive of Design History, ... Product , Process and Service documentation in support of ...or equivalent experience required.BS+7 or MS+4 years' experience in product development, manufacturing and / or quality… more
- Takeda Pharmaceuticals (Lexington, MA)
- …products. This key technical role is responsible for change controls, manufacturing process validation, device product complaints, regular review of DHF, ... for drug delivery including combination products, solid understanding of polymeric medical device manufacturing processes via molding and assembly, and solid… more
- Lilly (Indianapolis, IN)
- … changes crucial to maintain, sustain and improve the manufacturing process . + Coordinate/lead multi-functional/cross-site/cross-company engineering project ... Service. + Complete engineering activities involved in the development of process / product improvements. This includes project planning activities, development of… more
- Lilly (Indianapolis, IN)
- … changes necessary to maintain, sustain and improve the manufacturing process . * Coordinate/lead cross-functional/cross-site/cross-company engineering project ... with Contract Manufacturer(s) (CM) and Original Equipment Manufacturer (OEM) to provide process engineering support to operations, product supply, quality, and… more
- Lilly (Indianapolis, IN)
- …automated assembly equipment utilized as part of the manufacturing process . These equipment deliveries support new product launches, capacity expansions ... people who are determined to make life better for people around the world. Indy Device Manufacturing (IDM) is an external facing team responsible for the … more
- Merck (Rahway, NJ)
- …+ Identify and implement process improvements by working collaboratively with device technical operations and manufacturing sites on existing and new ... **Job Description** As a Senior Engineer in Device Design and Process Development group,...ISO 14971 etc.) and industry standards related to medical device manufacturing is a plus. + Prior… more
- Lilly (Indianapolis, IN)
- …**Responsibilities:** Delivery Device and Connected Solutions (DDCS) and Indianapolis Device Manufacturing (IDM) leads all aspects of the development, ... and GMARS or similar computerized maintenance management system. + Knowledge of device manufacturing processes, equipment, and manufacturing operations.… more
- Merck (West Point, PA)
- …- Device Technical and Engineering Lead (Sr. Director Equivalent)** _Our company's Device Product & Process Development Team designs, develops, and ... effective delivery to their intended site of action. The Device Product & Process Development...individual will be expected to apply his/her knowledge of product design and development; manufacturing process… more
- Merck (Rahway, NJ)
- …in injection molding, automation, complex assembly and packaging operations for medical device or combination product component manufacturing , with ... solving, identification of root cause provide solutions. + Build and enhance device or combination product technology transfer programs in both development… more
- Merck (West Point, PA)
- … Device Technology Operations under the **Technology Transfer and Device Product Stewardship** groups supporting commercialization and lifecycle management ... Utilize device risk management tools to build device or combination product risk management programs...inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here… more
- Amgen (Cambridge, MA)
- …lead. + Provide direction and support for all technical documentation ( Device Design/Testing, Design Outputs, Manufacturing equipment/ process /control and ... manufacturing processes (injection molding, assembly processes) + Experience in drug/ device combination product design and development + Demonstrated… more
- AbbVie (North Chicago, IL)
- …to sustaining product quality, equipment qualification, and manufacturing process validations. As such, the Manager, Medical Device External Quality ... the Manager, Medical Device External Quality, may support New Product Introduction activities, with particular emphasis on transfer-to- manufacturing . The… more
- Merck (North Wales, PA)
- …of drug- device combination products + Experience in combination product regulatory development and manufacturing + Understanding ofIDE/IND/510(k) ... for due diligence of potential suppliers, partners, or acquisitions. + Assess global device and combination product regulatory intelligence and assist in the… more
- Lilly (Indianapolis, IN)
- …maintenance). + Provide quality support/consulting for TS/MS device manufacturing for design verification, molding packages, process validation (component, ... volunteerism. Delivery Device and Connected Solutions (DDCS) and Indianapolis Device Manufacturing (IDM) leads all aspects of the development,… more
- Global Foundries (Malta, NY)
- …advanced technology nodes on GLOBALFOUNDRIES' strategic roadmap.Essential Responsibilities: + Define device targeting and conditions on New Product Introductions ... into production ramp. + Drive Model to Silicon gaps & improve its implication on product performance. + Investigate root cause of Device , yield and product … more
- Merck (Rahway, NJ)
- …**Job description** This position will be responsible for leading and implementing medical device and combination product design controls for both new products ... 5 years related experience + Experience with the development drug- device combination product or a medical ...inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here… more
- Lilly (Durham, NC)
- …a safe work environment. + Setup and operate highly automated equipment in the Device Assembly area. + Provide leadership on manufacturing floor ensuring high ... Description:** The Operations Line Leader will be a key part of the Device Assembly team at RTP, where autoinjector devices are assembled. Line Leader will… more
- AbbVie (North Chicago, IL)
- …FMEA activities for device software & mobile apps. + Drive change management process for device software / mobile app launches and market expansions. + ... Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Manager, Medical Device Quality - Software will act as the global... Quality - Software will act as the global product quality lead in support of a broad portfolio… more
