Medical Device Manufacturing Engineer

ESSENTIAL DUTIES AND RESPONSIBILITIES including the following. - primarily responsible for being Technical Lead 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. Project lead technical lead - Proven Mfg. plant medical device product and process development experience owning and driving projects to fruition, with a proven work ethic and consistently exceeding results - Plan, 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 system - IQ, 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. - Work within medical device Quality system ISO13485 for execution of change controls and Design control activities - Is required to setup/update ERP system related to new medical device product. Creation of documents, master data etc. - Demonstrated proficiency in equipment and tooling procurement and process design and development (assembly and associated process development) - Follow-up with Work Stream Leads from medical device Manufacturing Plants and to assimilate project information daily - Understanding and ability to execute DOEs, process validations and process characterizations for medical device process development -Technical execution of the work and achieve the defined milestones as targeted. Creates and reviews risk assessments and FMEA Oversees and is accountable for overall compliance administration activities relating to QSR, design controls, validations and CAPA Provides 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 validations Performs supplier quality system audits. General quality control and compliance - Primary work location- San Diego CA QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/ or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Expertise working in medical device manufacturing plant for medical/ pharma industry. Expertise in medical device technical writing of protocols, validation plans etc Strong interpersonal skills required in the areas of verbal and written communications, time management and professionalism Strong information management skills. Strong analytical thinking, questioning & problem-solving skills. EDUCATION and/or EXPERIENCE Minimum undergraduate degree (BS) in Science, Mechanical/Industrial/Biomedical engineering 4Years of medical device product and process development experience in a manufacturing plant setting

• Experience leading large technical projects in medical industry