Senior Manufacturing Engineer

Hello
Greetings of the day.
This is Vydehi from Intellectt Inc. We currently have an opening for a Manufacturing Engineer with one of our medical device clients. If you or anyone you know is interested in this opportunity, please feel free to send your updated resume to or reach out to me directly at .
Role: Manufacturing Engineer II


Location: Westbrook, ME


Duration: 12 Months Responsibilities Job Description: Develop, implement, and optimize manufacturing processes and equipment. Utilize structured problem-solving techniques to identify root causes of failures and implement preventive measures. Troubleshoot equipment by evaluating machine logic, electromechanical systems, and process controls. Conduct design of experiments, validation, testing, and data analysis for continuous improvement initiatives. Recommend and support new methods or materials to enhance quality and efficiency. Assess current equipment for process suitability and develop improvement plans. Prepare and revise manufacturing documents, SOPs, safety instructions, and other technical documents. Collaborate with engineering teams to develop solutions and enhancements. Participate in teams to ensure continual improvement, safety, and compliance. Provide training and expertise for product processing and tooling development. Lead engineering project teams and coordinate activities. Mentor junior engineers and maintenance 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 combination of education and 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 and practices. Knowledge of statistical analysis software (e.g., Minitab).