Job Description

1 week ago Be among the first 25 applicants Direct message the job poster from ApTask Lead teams in the development of drug delivery devices. Scope includes a wide range of devices, such as needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices. The Principal Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices. The role of the Principal Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development. Responsibilities Work cross-functionally with individuals and project teams in Marketing, Operations, and Development Create and assess product requirements to determine technical coverage and proper integration of subsystems Create and execute project plans and schedules Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plans, verification and validation plans and other related product development documents for assigned projects Provide deep technical assistance for junior engineers Qualifications & Skills BS in Engineering and previous experience in a medical device industry 10+ years of experience with engineering processes and procedures Led projects from development through the 510(k) and PMA approval process Strong background in engineering and commercialization of electro-mechanical medical devices Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510(k)) submissions Experience in drug/device combination product design and development Familiar with Quality System Regulation 21CFR820, Risk Management ISO 14971, EU Medical Device requirements, Medical Electrical Equipment EN 60601 Small scale device assembly experience Strong problem solving, risk assessment, and risk management skills Must be capable of working on multiple projects in a deadline driven environment About ApTask ApTask is a leading global provider of workforce solutions and talent acquisition services, dedicated to shaping the future of work. Join us to connect businesses with top-tier professionals and drive success across diverse industries. #J-18808-Ljbffr ApTask

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