Manufacturing Engineer

Job DescriptionPosition: Manufacturing EngineerLocation: San Diego, CADuration: 06 Months+Job Description:Primarily responsible for engineering support for manufacturing operations and Mfg. quality activities to at the site. Proven experience owning and driving projects to fruition, with a proven work ethic and consistently exceeding results. Proven Mfg. plant medical device product and process development experience owning and driving projects to fruition, with a proven work ethic and consistently exceeding resultsPlan, coordinate and manage all manufacturing activities associated with commercialization and launch of new medical device and pharmaceutical products. Medical device Manufacturing process Development and management of a transition plan and team Process documentation transfer coordination & preparation Equipment moves/ setup and installation Technical writing of protocols, Engineering tests as per medical device part 21 CFR Quality systemIQ, OQ, PQ protocol development and execution support Production startup and training support. Is required develop technical documentation in medical device product development such as Buyspecs, Manufacturing procedures, Test methods etc. Is required to develop/author medical device development validation plans, test protocols etc and independently required to execute them as well. Creates and reviews risk assessments and FMEAOversees and is accountable for overall compliance administration activities relating to QSR, design controls, validations and CAPAProvides support for project teams or Quality department as required. Provides work direction as required. Creates and reviews quality system documentation. Maintains validation master plan. Builds protocols, test methods, Product validationsPerforms supplier quality system audits. General quality control and complianceQualificationsExpertise working in medical device manufacturing plant for medical/ pharma industry. Expertise in medical device technical writing of protocols, validation plans etcStrong interpersonal skills required in the areas of verbal and written communications, time management and professionalismStrong information management skills. Strong analytical thinking, questioning & problem-solving skills. EDUCATION And/or EXPERIENCEMinimum undergraduate degree (BS) in Science, Mechanical/Industrial/Biomedical engineering 4Years of medical device product and process development experience in a manufacturing plant setting