Manufacturing Engineer II - Westbrook, United States - Axelon

Description

Job Title:
Manufacturing Engineer IILocation: Scarborough, ME
Shift Timings: 8 AM - 5 PM (Monday through Friday)

Responsibilities:
Develop processes, specify equipment, acquire and implement it. Identify root causes of manufacturing failures using structured problem-solving techniques and implement fixes to prevent recurrence. Troubleshoot equipment by evaluating machine logic, electromechanical systems, and process controls. Conduct design experiments, validations, tests, and data analysis for continuous improvement projects, and present findings to equipment teams. Propose and support new methods or materials to improve quality and efficiency. Analyze current equipment for process suitability and create detailed improvement plans. Create and update manufacturing documents, SOPs, safety instructions, validation protocols, and technical documents to ensure compliance and safety. Collaborate with engineers and technicians to develop solutions and improvements in materials, equipment, and processes. Participate in teams to ensure continuous improvement, safety, and compliance. Provide training and expertise in process development, tooling, and validation. Manage engineering project teams and mentor junior engineers and technicians. Initiate and resolve Quality Incidents and CAPA. Ability to travel up to 25% of the time.


Basic Qualifications | Education:
Bachelor's degree (BS) in engineering or equivalent experience. Minimum three years of engineering experience in a manufacturing environment. Familiarity with material testing and measuring methods. Proficiency in Database, CAD, Development, Internet, Inventory, Manufacturing, Project Management, Microsoft Excel, and Microsoft Word software.


Preferred Qualifications:
Experience in GMP, FDA, ISO, and USDA regulated environments. Familiarity with cGMP and ISO 13485 regulations. Experience with statistical analysis software (e.g., Minitab).


Competencies:
Ability to work with mathematical concepts such as ANSI/AQL, probability, and statistics.