Manufacturing Engineer - FDA GMP ISO CAD DVM - CT
Location: US, CT, Bridgeport
Employment type: Full-time
Company profile: We Provide Full Time Permanent Positions for many medium to large US companies. We are interested in finding/recruiting high quality candidates in IT, Engineering, Manufacturing and other highly technical and non-technical jobs.
Description:  Experienced Manufacturing Engineer is required having responsibility to participate or lead cross-functional teams during product development to ensure design for manufacturability, process development, manufacturing documentation, and pilot operationsD - 141 Job Responsibilities: Participate or lead cross-functional teams during product development to ensure design for manufacturability, process development, manufacturing documentation, and pilot operationsSelect, develop, and validate manufacturing processes, equipment, and toolingSupport production through efficient and effective identification and resolution of line issuesIdentify, initiate, and execute process, cost reduction and product improvement projectsProperly document activities in accordance with best engineering practices, company procedures and regulatory requirementsFollow good project management practicesInterface with external vendors to source parts, equipment and fixturesInterface with external vendors to resolve supplier quality and process capability issuesDuring product life-cycle:Initiate engineering change requestsStructure Bills of Material (BOM)Investigate and complete corrective and preventive action (CAPA) assignmentsEffectively train operators, technicians, and engineers on use of equipment and fixturesParticipate and drive continuous improvement projects related to manufacturingParticipate in product development and provide input from a manufacturing perspective  
Requirements: 5-7 years of experience in manufacturing related industryManufacturing experience in a medical device company a plusWorking experience with optical components (photodetectors, LEDs)Min 1-2 years of experience developing and deploying LabView softwareFamiliarity with Food and Drug Administration (FDA) Guidances, Good Manufacturing Practices (GMP's), and applicable ISO standards (ISO 13485, ISO 14971, etc.)Working ability to review and modify CAD drawings and documentation; familiarity with Solid Works software and PDM a plusWorking knowledge of electrical test equipment (DVM, Oscilloscope, etc.)Good understanding of Six Sigma quality guidelines, certification a plusAbility to solder for prototype designsGood knowledge of IEC solder standardsGood laboratory practicesAbility to use a microscopeFamiliarity with SQL-based electronic databasesMust be able to understand, read, write, and fluently speak the English language.Ability to understand and follow established methods and procedures.Proficient in Microsoft Office Suite (including Project)Excellent communication skills (verbal and written).  Must be able to communicate across many different levels of the organization.Ability to work effectively and respectfully in a team environmentLogical thinker, creative thinker, and good problem solverDemonstrated ability to successfully work with minimal supervision.Ability to travel domestically and internationally, which can include overnight and weekendsMust be able to understand and follow established methods and procedures.Educational Qualifications:Associate or Bachelor's Degree (BS) in engineering discipline with strong hardware (mechanical / electrical) component focusWe Provide Full Time Permanent Positions for many medium to large US companies. We have more than 1500 jobs available in our website. Our website has thousands of openings and these job openings are not posted anywhere else online. When you apply online through our website, it automatically forwards your information to the recruiter handling your applied job. If you are a close match, they will contact you immediately to discuss about the positions and do everything to get you an interview with the client as quickly as possible. Visit  : STI Professional Services 
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