Senior Manufacturing Engineer - Medical device

Job Title: Senior Manufacturing EngineerLocation: Southern NH (Onsite)Duration: 12 Months ContractJob OverviewWe are seeking a Senior Manufacturing Engineer to support the modernization of legacy manufacturing processes and production documentation in a regulated medical device environment. This role focuses on implementing manufacturing controls based on risk management outputs, ensuring compliance, efficiency, and product quality.Key ResponsibilitiesDevelop, update, and revise manufacturing work instructions, assembly procedures, drawings, and equipment documentationReview DHFs and Risk Management Reports to identify CTQs and implement appropriate manufacturing controlsDevelop and maintain PFMEAs, including process inputs, failure modes, and risk assessmentsCreate and implement Control Plans based on PFMEAs, including monitoring and reaction strategiesSupport development, validation, and optimization of manufacturing processes, assembly methods, and test methodsExecute Test Method Validation (TMV) and Computer System Validation (CSV) activitiesSupport Process Validation activities (IQ/OQ/PQ) for manufacturing equipment and processesEvaluate and support automated production equipment (filling, capping, bottling, mixing systems)Collaborate with Quality and Validation teams to maintain validated processes during productionParticipate in design reviews to ensure manufacturabilityLead root cause analysis and implement CAPA for manufacturing issuesEnsure compliance with GMP, ISO standards, QMS, and safety regulationsDrive continuous improvement initiatives (Lean, Six Sigma, etc.)Required QualificationsBachelor’s or Master’s degree in Mechanical, Industrial, Manufacturing, Biomedical, Electrical Engineering, or related field6+ years of manufacturing engineering experience in regulated environments (medical device preferred)Hands-on experience with Process Validation (IQ/OQ/PQ) and Test Method Validation (TMV)Strong knowledge of risk management tools (PFMEA, control plans)Experience troubleshooting electromechanical, pneumatic, and software systemsWorking knowledge of medical device regulations: 21 CFR, ISO 13485, ISO 14971, IVDRFamiliarity with IPC standards, ANSI, and GD&TExperience with process improvement methodologies (Lean, Six Sigma, DFM, VAVE)