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About the Role

This position is responsible for developing and implementing cost-effective manufacturing processes and methods, recommending improvements to production processes, and coordinating the launch of new products into volume production for a Medical Device manufacturer.

Responsibilities

• Support Production in reducing/eliminating equipment and tooling downtime or scrap.
• Perform tool life studies to drive efficiency and cost savings.
• Conduct Process Capability studies during manufacturing processes.
• Collaborate with cross-functional teams during production transfer to establish and launch robust processes.
• Improve manufacturing processes, methods, and controls for cost reduction, quality improvements, and efficiency.
• Prepare engineering change orders and coordinate deployment, including training.
• Develop and improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality, and safety performance.
• Develop and qualify tools and equipment for manufacturing processes.
• Perform product and process analysis for cost reduction, quality improvement, and efficiency.
• Utilize risk management tools (e.g., PFMEA) to identify potential risks and corrective actions.
• Support equipment qualification and process validations (IQ, OQ, PQ).
• Troubleshoot manufacturing processes when defects occur, leading investigations for root cause and countermeasures.
• Train Engineering and Operations personnel on manufacturing processes/equipment.
• Disposition non-conforming products and develop re-work procedures.
• Lead Kaizen events and drive continuous improvement efforts.
• Adhere to the Quality Management System.
• Perform other duties as assigned.

Requirements

• High attention to detail.
• Ability to read drawings and specifications containing GD&T.
• Proficiency in SolidWorks.
• Proficient in the use of Microsoft Office and Adobe products.
• Solid knowledge of GMP and ISO 13485 regulations.
• Experience with continuous improvement activities, including participation and/or facilitating Kaizen events using lean manufacturing principles.
• Ability to work in a fast-paced Medical Device Manufacturing environment with high output efficiency and impeccable quality standards.
• Ability to bend, stoop, squat, kneel, and lift up to 20 pounds.
• 20/20 vision (assisted or unassisted) required for sorting raw and non-conforming materials.
• Good dexterity for managing small to medium products.
• Exposure to oil, grease, dust, metal particles, sparks, sharp-edged materials.
• Perform keyboard entries with possible frequent operation of a computer.

Skills

• SolidWorks
• Microsoft Office
• Adobe products
• GMP
• ISO 13485
• Lean manufacturing principles
• Kaizen events
• Risk management (PFMEA)
• IQ, OQ, PQ
• Time management
• Prioritization
• Independent work
• Teamwork
• Verbal communication
• Written communication

Location

• Berlin, CT

Work Type

• Full-time

Experience Level

• Minimum of 5 years’ experience

Education Level

• Bachelor’s degree in an engineering discipline or equivalent experience

About the Company

• TOMZ manufactures parts via high precision metal machining, finishing, assembly, and anodize processes for Medical Devices.