Sr. Manufacturing Engineer

Job Title:

Sr.

Manufacturing Engineer Location:

5 Bradley Drive, Westbrook, ME 04092

Duration:

3

Months Work Arrangement:

100%

Onsite Pay Range:

$54 - $57 per hour (W2) We are seeking a "Sr. Manufacturing Engineer" to join one of our leading healthcare clients. Position Overview We are seeking a Senior Manufacturing Automation Engineer to support manufacturing operations within the Infectious Disease Developed Markets Business Unit based in Scarborough, Maine. This role focuses on optimizing manufacturing processes, driving quality and cost-efficiency initiatives, and ensuring compliance with cGMP, FDA, and ISO standards. Key Responsibilities Ensure compliance with company policies, procedures, and regulatory requirements (FDA, ISO, cGMP). Support manufacturing operations, process improvements, and cost-saving initiatives. Lead automation equipment upgrades related to safety, obsolescence, and continuous improvement. Troubleshoot equipment issues involving machine logic, electromechanical systems, and process controls. Perform root cause analysis and implement corrective and preventive actions (CAPA). Conduct risk assessments and Failure Modes and Effects Analysis (FMEA). Lead design of experiments (DOE), validation activities, testing, and data analysis. Develop and maintain manufacturing documentation including SOPs, validation protocols, and specifications. Drive implementation of new methods, materials, and technologies to improve efficiency and quality. Analyze equipment performance and recommend process improvements. Lead cross-functional teams and manage project activities and timelines. Provide technical training and mentorship to engineers and technicians. Support change management initiatives and participate in site strategy planning. Ensure effective collaboration with internal teams, vendors, and stakeholders. Required Qualifications Bachelor's degree in Engineering or equivalent experience. 7+ years of experience in a manufacturing environment. Experience with Lean Six Sigma methodologies (DMAIC or similar). Strong understanding of change management principles. Preferred Qualifications Experience working in regulated environments (FDA, ISO, GMP, ISO 13485). Familiarity with statistical analysis tools. Proficiency in Microsoft Office (Excel, PowerPoint, Power BI). Core Competencies Strong analytical and problem-solving skills. Ability to manage multiple priorities effectively. Excellent verbal and written communication skills. Self-motivated with a proactive and results-driven approach. Strong teamwork and collaboration skills. Technical Skills Knowledge of fabrication and manufacturing processes (CNC, machining, welding). Ability to interpret technical drawings and engineering instructions. Experience with CAD and manufacturing software. Understanding of statistical methods and quality standards. Experience with materials testing and performance evaluation. We are looking for the candidate who are eligible to work with any employers without sponsorship . If you're interested, please click "Apply" button.