- AbbVie (North Chicago, IL)
- …Combination Product Development , R&D. This individual will contribute to the development of exciting new drug/ device combination products for various ... Senior Embedded Firmware Device Engineer who has experience in development of electromechanical devices/ combination products primarily with a Software… more
- Merck (Rahway, NJ)
- …focuses on the design, development , and commercialization of novel biologic/drug/vaccine- device combination products for safe and effective delivery to their ... sites of action. The DPPD Team oversees the development of the device constituent within our pipeline of combination products, spanning various therapeutic… more
- Merck (Rahway, NJ)
- …suppliers. + Proactively resolve project obstacles and challenges and communicate device development strategy and design controls approach within Device ... one of the above disciplines plus 5 years related experience + Experience with the development drug- device combination product or a medical device … more
- Takeda Pharmaceuticals (Lexington, MA)
- … device and combination device regulations. + Lead project execution activities and oversee the development of statistically sound design verification ... project and engineering leadership in the concept, feasibility, development , qualification and launch phases of device ...**or** PhD and 0+ years in the field of combination product or medical device development… more
- Merck (Rahway, NJ)
- …experience of managing complex device or combination product development programs and leading cross-disciplinary project teams. + Has broad knowledge ... Lead and set direction for the device development strategy for multiple drug- device combination...and engineering execution against the established requirements. + Represent Device Development and the project -specific… more
- Sanofi Group (Morristown, NJ)
- …Development , manufacturing, quality, supply chain) and drug product development . Combination product and drug delivery device systems technology is often ... on assigned projects. The role will represent the GRA Device perspective as a member of project ...lifecycle management activities for device aspects of combination product submissions. + Contribute to product development… more
- Lilly (Indianapolis, IN)
- …transfer to contract manufacturing operations. Provide technical leadership starting in early device development phases to identify and define processes for ... and / or to support build requests from Lilly device development / asset delivery projects. Create...Troubleshoot new applications of technology in support of capital project execution. + Support the design of equipment for… more
- Merck (Rahway, NJ)
- …develop robust equipment and processes for clinical and commercial manufacture of drug- device combination products. + Understanding of parenteral delivery ... **Job Description** As a Senior Engineer in Device Design and Process Development group,...equipment design, conduct line trials including FAT and report project progress, risks, and mitigations to the team. +… more
- AbbVie (Irvine, CA)
- …This individual will contribute to the development of exciting new drug / device combination products for various phases of clinical studies and work closely ... and sought out as an expert in the field, effectively leading cross-functional device development teams through feasibility, design control phases, and life… more
- Merck (West Point, PA)
- …+ Utilize device risk management tools to build device or combination product risk management programs in development and life cycle management + Utilize ... product needs for commercial products + Facilitate technology transfer of medical device and combination products from development to commercialization This… more
- Astellas Pharma (Northbrook, IL)
- …policies and develop strategies for compliance. + Directs and maintains Device / Combination product development strategy following current regulations ... **Director CMC Development PRTL Packaging & Device US**...+ Provides leadership, and guidance to direct reports and project team members in an effort to develop strong… more
- Merck (Rahway, NJ)
- …of root cause provide solutions. + Build and enhance device or combination product technology transfer programs in both development and lifecycle management, ... Director of Device Technology is a key leadership role within the Device Development and Technology Organization. This position is responsible for building… more
- Takeda Pharmaceuticals (Boston, MA)
- …strategic insight, and guidance to internal stakeholders, including Clinical, Device Development , Pharmacovigilance, Legal, Scientific, Commercial, to ensure ... alignment for other medium and/or high complexity products (including combination , Software as a Medical Device , and...Must have a detailed understanding of pharmaceutical drug and device development and global regulations pertaining to… more
- US Tech Solutions (North Chicago, IL)
- The Project Manager, ** Combination Products** Development is accountable for leading the cross functional team (Engineering, Quality, Supply Chain, ... not required * **8+ years of experience in the combination product** or medical device industry with...understanding of the pharmaceutical and device **product development cycle.** * **Design history file** , project… more
- Amgen (Cambridge, MA)
- …understanding of manufacturing processes (injection molding, assembly processes) + Experience in drug/ device combination product design and development + ... the world. In this vital role you will support device development and design control documentation. In...DHF documentation to ensure a clear line between platform, combination product and vendor DHF structuring + Own risk… more
- Takeda Pharmaceuticals (Boston, MA)
- …will work closely with colleagues in Medical Safety, LOCs, Global Clinical Development , Global Regulatory Affairs, Device Quality, PV Compliance etc. ... complaint handling teams to resolve inconsistencies or inaccuracies in device complaint evaluation. + Effectively communicate project expectations… more
- AbbVie (North Chicago, IL)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Manager, Medical Device Quality - Software will act as the global product quality lead ... of on-market medical devices including Software as a Medical Device (SaMD) and Software in a Medical Device...System and Digital Heath initiatives. + Participates in the development of global Product Quality Assurance strategy to support… more
- Pfizer (Parsippany, NJ)
- …for device lifecycle management of on-market medical devices and combination products + Develop change management technical impact assessments, design and ... and 8 years of relevant experience. + Prior experience in Medical Device or Combination Products Design Controls, Production, Sustaining Engineering, or… more
- Merck (Rahway, NJ)
- …JANUS IT system. This position interacts closely with cross functional teams, including Device Development & Technology (DD&T), working in the system in support ... to act as Lead System Owner of the Medical Device and Combination Product (MDCP) Design Controls...guidance to our Manufacturing Division and our Research & Development Division device functions and other personnel… more
- Merck (Rahway, NJ)
- … Device Technical Operations is a pivotal leadership role within the Device Development & Technology (DD&T) organization in our Research Division. This ... for the technical transfer portfolio for medical devices and combination products, as well as combination product...in the department of approximately 50 employees, spanning multiple development projects and inline products across a range of… more