- Merck & Co. (Rahway, NJ)
- …suppliers. Proactively resolve project obstacles and challenges and communicate device development strategy and design controls approach within Device ... design control activities in the following aspects: Lead and contribute device development design controls for the assigned projects.- Prepare materials… more
- Merck & Co. (Rahway, NJ)
- …robust equipment and processes for clinical and commercial manufacture of drug- device combination products.Hands on troubleshooting in a manufacturing ... Job DescriptionAs a Senior Engineer in Device Design and Process Development group,...conduct line trials including acceptance testing (FAT) and report project progress, risks, and mitigations to the team.Author protocols,… more
- Merck & Co. (Rahway, NJ)
- …Biochemistry, Combination Products, Compliance Remediation, Cross-Cultural Awareness, Device Development , Document Control Systems, Employee Training ... demonstrated capability in Regulatory CMC, this candidate will contribute to and implement Device and Drug- Device Combination regulatory strategies for our… more
- Merck & Co. (Rahway, NJ)
- …have demonstrated understanding and experience of unique requirements of packaging system development of Medical Device and Combination Products, including ... packaging science or engineering, process engineering, packaging production operations, device development and commercialization, leading cross-functional product… more
- Merck & Co. (Rahway, NJ)
- …regulatory landscapes for medical device and medical device combination products.Collaborate with GRACS, Device , Development & Technology (DD&T), ... regulatory compliance for the company's portfolio of medical devices and medical device combination products. Primary activities include, but are not limited… more
- Merck & Co. (Durham, NC)
- …and Skills: Manufacturing - Injection Molding and Automated Assembly of Medical Device Components. Final Assembly and Packaging of Combination Products. ... with External Partners that manufacture, assemble, and test complex injection molded Device Components, Device Constituents, and Medical Devices used to deliver… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …related experience; including hands on related pharmaceutical or medical device /pharmaceutical combination product experience and actual regulatory experience ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...support of research and marketed products Create and maintain product/ project database to record history of questions asked /… more
- Sanofi Group (Cambridge, MA)
- …a project or functional context + Poven experience in drug/ device combination product regulatory approvals + Demonstrate strategic thinking, initiative, ... key stakeholders including clinical, medical affairs, R&D, Manufacturing & Supply ( device development , manufacturing, quality, supply chain) and Global Business… more
- Merck (Rahway, NJ)
- …suppliers. + Proactively resolve project obstacles and challenges and communicate device development strategy and design controls approach within Device ... design control activities in the following aspects: + Lead and contribute device development design controls for the assigned projects. + Prepare materials… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- Regeneron is currently looking for a Principal/Staff Device Development Engineer to join our project lead team. This is a non-lab based position. They will ... drive the end-to-end platform development of a device combination ...project coordination. To be considered for the Principal/Staff Device Development Engineer you must have a… 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
- 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)
- …and plans + Work with Procurement, Manufacturing Finance, and Device Development teams to establish capital estimates, project budgets, and volume-based COPS ... value and reliability **Minimum Requirements:** + 5+ years of experience in asset/ project delivery and/or medical device development & commercialization… more
- Merck (Rahway, NJ)
- …develop robust equipment and processes for clinical and commercial manufacture of drug- device combination products. + Hands on troubleshooting in a manufacturing ... **Job Description** As a Senior Engineer in Device Design and Process Development group,...conduct line trials including acceptance testing (FAT) and report project progress, risks, and mitigations to the team. +… more
- Amgen (Thousand Oaks, CA)
- …and International Quality Management Systems for Medical Devices (ISO 13485). + Drug- Device and Biologic- Device Combination Product Requirements for cGMP. ... ISO 14971 and ISO 11608. + Laboratory equipment and techniques for drug delivery device development and testing. Managing laboratory assets and test samples. +… more
- Actalent (Plymouth, MN)
- …seeking a highly skilled and experienced Senior Chemist to join our R&D team supporting combination medical device development . This role is ideal for a ... medical device or pharmaceutical industry. Proven expertise in combination product testing, method development , and instrument troubleshooting. Proficiency… more
- Takeda Pharmaceuticals (Lexington, MA)
- …tooling, equipment, and specifications; establish and foster collaborative relationships with internal device and combination product development and quality ... job opportunity: **JOB LOCATION:** Lexington, MA **POSITION** : Staff Engineer, Device Testing **POSITION DESCRIPTION** : Takeda Development Center Americas,… more
- Battelle Memorial Institute (Columbus, OH)
- Battelle delivers when others can't. We conduct research and development , manage national laboratories, design and manufacture products and deliver critical services ... be a core team member in the design and development of medical and commercial products and systems. This...human factors, and other engineers as needed for the project . You will work closely with the program manager… more
- Battelle Memorial Institute (Columbus, OH)
- Battelle delivers when others can't. We conduct research and development , manage national laboratories, design and manufacture products and deliver critical services ... all qualified individuals to apply. **Job Summary** The Medical Device Solutions team is seeking a **Mechanical Technician** as...as a core team member in the design and development of medical products and systems. This role assists… more
- Fujifilm (Durham, NC)
- **Position Overview** This person will be a member of the Sustaining Development Team. They would work on a combination patches and hotfixes to support our ... Description** **Duties and Responsibilities:** + Understand the scope/requirements of the project from requirements, user stories and interactions with the team. +… more
