Job Title: Manufacturing Engineer

Location: North Haven, CT (Onsite)

We are seeking a skilled and experienced Manufacturing Engineer to join our team. The ideal candidate will collaborate with cross-functional teams, including Quality Engineering, to provide manufacturing support for medical device production. This role requires expertise in process improvement, equipment design, and troubleshooting in a regulated manufacturing environment.

Key Responsibilities:

• Collaborate with Quality Engineering to provide manufacturing support for medical device production.
• Support specific projects with change analysis, risk analysis, and ensure manufacturing readiness.
• Conduct time studies for various assembly lines to optimize processes and identify efficiencies.
• Troubleshoot and resolve issues related to safety, efficacy, quality, cost, or delivery of components and finished devices.
• Perform qualification, verification, and validation activities to ensure compliance and quality in medical device manufacturing.
• Contribute to new product development by supporting technology development, material/product testing, preparation of specifications, and process improvements.
• Lead six sigma initiatives, process studies, and process improvements to optimize yield, efficiency, throughput, and performance.
• Design, procure, and fabricate tooling and fixtures to support production processes.
• Develop, document, and improve manufacturing processes to ensure the safety and efficacy of finished devices.
• Train, mentor, and provide guidance to operators and technicians on manufacturing processes.
• Participate in cross-functional teams, managing project work, documenting progress, and recommending revisions as needed.
• Assist with design control efforts, including failure mode and effects analysis (FMEA) and design reviews.
• Collaborate with cross-functional teams (CFT) to troubleshoot production floor issues and implement solutions.
• Continuously identify opportunities for process/product improvements to increase efficiency and performance.
• Design, develop, test, and validate equipment and processes. Analyze process models and recommend improvements.

Qualifications:

• Bachelor's Degree in Packaging Science, Mechanical Engineering, or a related field. A Master's Degree in Engineering is a plus.
• A minimum of 3 years of relevant experience in packaging engineering, medical device manufacturing, pharmaceuticals, or a related industry.
• Strong understanding of Mechanical/Manufacturing Engineering principles.
• Experience in time study analysis for assembly lines.
• Knowledge of medical device manufacturing regulations and standards.

Preferred Skills & Experience:

• Familiarity with six sigma methodology and process improvement tools.
• Experience working in a regulated environment (e.g., ISO 13485, FDA).
• Ability to work independently and manage multiple projects simultaneously.
• Strong problem-solving skills and the ability to troubleshoot complex issues in a manufacturing environment.