What are the responsibilities and job description for the Senior Project Engineer position at ACL Digital?
Title : Senior Engineer
Location : Thousand Oaks, CA
Duration : 12 months contract
Ideal Candidate : B.S. 5 YOE experience in root cause investigations, change controls, deviations, and CAPA.
Nice to have : Minitab and Pharma or med device background.
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 Senior 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 Senior 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 different subsystems. - Create and execute to project plans and schedules - Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
Provide deep technical assistance for junior engineers. Skills : - BS in Engineering and previous experience in a medical device industry - Experience with engineering processes and procedures. - 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 / 510k) submissions.
Experience in drug / device combination product design and development - Small scale device assembly experience. - Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. - Strong problem solving, risk assessment, and risk management skills. - Must be capable of working on multiple projects in a deadline driven environment.
