Device Engineer

Job Specific InformationSummaryAn individual with extensive ( > 10 years ) engineering depth and breadth in both technical and supplierproject management. The technical expertise should be automation process development and validation and device design verification (see below for details). This background enables the individual to be deployed to a wide array of Device Engineering needs with little direction and little to moderate support.Essential Duties and ResponsibilitiesProject Supplier Management Skills:Device Engineering at Transpire Bio primarily drives development (product design, manufacturing, supply chain) via leveraged external teams. To make a contribution in this environment, the Device Engineer must be comfortable collaborating with global teams on distributed projects (e.g. CMO in US, prototyping in Asia, design in Europe, pharmaceutical in Weston). This role has excellent communication and information management skills.Technical Expertise:In addition to project management skills, this role has considerable technical proficiency in Mechanical Engineering. Preferred specializations include Automation, Process Development, and ideally Validation. The individual is able to quickly come up to speed on a wide variety of technical matters associated with the Device and also at the interface between the Device and Pharmaceutical. This includes manufacture (design) transfer, design verification and validation, and ultimately registration of the device. Heshe is also able to quickly comprehend external partner technical issues and anticipate the impact to Device and Project.Specific examples - typically work with external partners like CMO, consultants and test labs.Design (manufacturing) transfer: process development, testing, qualification, document generation and change control.Design verification: plan testing based on device nature and specs (including generate and update device specs).The device engineer makes tactical project decisions with Device Engineering Director informed and consults (or receives direction from) Device Engineering Director for any higher-impact strategic decisions.Qualification RequirementsA M.S, in Mechanical Engineering, Electrical Engineering, Material Sciences or related discipline with 3 to 6 years, B.S. with 8 to 12 years device development experience in pharmaceutical or related field.Experience with device development in the context of pharmaceutical R&D and product development is a must to have.Must possess expert knowledge of mechanical design with preference for SolidWorks.Must possess expert knowledge of tools to conduct statistical and tolerance analysis.Must possess knowledge of manufacturing processes including injection molding and metal machining processes.Must possess knowledge of regulations and standards including US 21 CFR Part 820, ISO 13485, ISO 14971, ISO 10993, EU MDR etc.Experience with device assembly processes including manual, semi-automated andor commercial scale automated processes is a plus.Experience in development of orally inhaled and nasal drug products (OINDPs) is a plus.Experience in mold tool design, optimization and qualification is a plus to have.Experience with Notified Bodies and CE marking is a plus.Strong English language skills including writing ability and oral communication.Demonstrates good judgment as well as cultural, social, and environmental awareness.

Created: 2025-02-21