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Oversee the end-to-end development of new medical devices, coordinating R&D, quality, regulatory, and manufacturing teams to bring regulated products from concept to market.
Leads test engineering for medical devices and IVD systems, defining validation strategies, test architectures, and regulatory compliance while coaching junior engineers and driving cross-functional problem-solving.
Develops, validates, and maintains production test systems for medical and IVD devices, ensuring compliance with regulatory standards and supporting manufacturing transfer.
Senior Design Quality Engineer ensures medical device designs meet regulatory standards (ISO 13485, FDA, EU MDR) by reviewing changes, managing risk, and leading cross-functional teams in compliance with Medtronic’s QMS. Core focus: hardware/software integration, reliability, and patient safety in acute care/monitoring devices.
Perform In-Process Quality Assurance (IPQA) activities such as sampling, BPR review, and line clearance on the shop floor, ensuring compliance with cGMP and ISO 13485 using SAP, Trackwise, and QAAS software.
The Project Manager oversees the full implementation lifecycle of software solutions, managing project plans, budgets, and cross-functional teams to ensure successful delivery and customer satisfaction. The role requires strong communication skills and proficiency in project management tools to coordinate between technical teams and clinical stakeholders.
Job Summary Responsible for management of Asia Quality System, Policies, Programs and Initiatives. Part of the Global Quality Team to maintain global quality system and drive global initiative. Role and…
Supplier Quality Assurance Team Lead Location: Onsite in Cirencester Are you an experienced Supplier Quality professional looking for an opportunity to lead a high-performing team and drive supplier excellence within a…
Regulatory Operations Project Coordinator Location: CirencesterJob Type: Full-time Hybrid after completion of probationDepartment: Regulatory Affairs We are seeking a highly organised and proactive Regulatory…
Maintenance Engineer Location: On site CirencesterSalary: £38,000 base plus Shift allowance Double Days 20% / Nights 33% and weekend Days (Fri/Sat /Sun) 28% Join Corin as a Maintenance Engineer At Corin, we're…
HistoSonics is a commercial-stage medtech company advancing the Edison® System, a novel non-invasive sonic beam therapy based on histotripsy. Since receiving FDA De Novo grant for the non-invasive destruction of liver…
Role Summary The Sr Manager Global Supplier Quality owns the global Supplier Quality strategy, governance model, and program for the business across all manufacturing sites and service and sales sites.. This role…
Project Manager, Libraries at Twist Bioscience manages all aspects of project management, coordination and implementation for gene mutant libraries (Site Variant Libraries and Combinatorial Variant Libraries), handling customer communications, coordinating library design inputs, preparing quotes, maintaining records, and ensuring regulatory compliance.
Job Purpose As the Senior Manager, NPI Quality, Consumer Technology , you will serve as the technical and operational authority responsible for executing the New Product Introduction (NPI) quality framework for…
TAE Life Sciences (TLS) is a biologically targeted radiation therapy company focused on developing novel treatment to improve the lives of patients with difficult-to-treat cancers. TLS has developed breakthrough…
Leads design verification for medical devices, creating test strategies, executing verification activities, and ensuring compliance with standards like ISO 13485/14971. Works with R&D, quality, and regulatory teams to validate device performance and requirements.
Primary Function of Position: Contribute your technical manufacturing, equipment design, process engineering, and project management skills to lead a dynamic and growing engineering team responsible for creating and…
Primary Function of Position: Senior Quality Engineer supports product development from concept through commercialization and will serve as the core team member for the cross-functional product development team. Senior…
Senior Scientific Platform Engineer US REMOTE (AZ, CA, CO, FL, GA, MA, MD, NC, NJ, NH, NV, OH, OR, PA, TN, TX) About VivoSense VivoSense is a science and technology company specializing in digital health technologies…
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