Manufacturing Engineer - Intellectt INC

Process Development & Improvement:

• Review new design changes for manufacturability and offer feedback.
• Design process improvements to reduce product cost, shorten cycle time, and enhance product quality.

Validation:

• Write and perform process validations (IQ/OQ/PQ) on equipment as required.
• Ensure processes and equipment meet standards for performance and safety.

Documentation & Compliance:

• Create documentation to support new or improved manufacturing processes.
• Ensure compliance with FDA, GMP, MDD, and ISO regulations.

Equipment & Tooling:

• Make recommendations for equipment purchases based on manufacturing needs.
• Perform experiments (including Design of Experiments (DOE)) to improve processes.

Quality & Issue Resolution:

• Handle Non-Conformance Reports (NCRs) and Corrective and Preventive Actions (CAPAs).
• Identify and resolve issues affecting product quality or manufacturing efficiency.

Collaboration:

• Work closely with manufacturing teams, supervisors, and engineers to interpret design intent and improve processes.
• Coordinate with suppliers and external resources to develop and implement new processes.
• Facilitate effective communication between team members and management.

Safety & Regulatory Compliance:

• Ensure all personal and company operations comply with Federal, State, and local regulations.
• Monitor subordinates' adherence to Health, Safety, and Environmental practices.

Education: Bachelor's degree in Engineering, Manufacturing, or a related field.

Experience:

• 4+ years of relevant work experience, preferably in a medical device manufacturing environment.
• Expertise in Design for Manufacturing (DFM), Design of Experiments (DOE), and Failure Mode and Effects Analysis (FMEA).
• Experience working in a fast-paced environment with minimal supervision.

Technical Skills:

• Proficient in Microsoft Office Suite (Word, Excel, Project, Outlook).
• Understanding of FDA, GMP, MDD, and ISO regulations.
• Strong Lean Manufacturing background preferred.

Soft Skills:

• Strong written, verbal, and interpersonal skills to interact effectively with all levels of employees and management.
• Ability to multitask and manage multiple priorities.