Manufacturing Engineer

Reporting to the Engineering Manager, this position will have direct responsibility for developing and implementing robust cost-effective manufacturing processes and methods, recommends and improvements to sustained production processes, methods, and controls, as well as coordinate the launch of new products into volume production. TOMZ manufactures parts via high precision metal machining, finishing, assembly, and anodize processes for Medical Devices.

Support Production in reducing / eliminating equipment and tooling downtime or scrap.

Perform tool life studies to drive efficiency and cost savings opportunities.

Conduct Process Capability studies during manufacturing processes to support achieving objectives.

Collaborates with cross-functional teams during the production transfer phase to establish and launch robust, mid to high volume processes.

Improves manufacturing processes, methods and controls for cost reduction, quality improvements and efficiency for both sustained and new products.

Prepares engineering change orders and coordinates the deployment of changes including training operation team members.

Develop and improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance for both sustained and new products.

Develop and qualify various tools and equipment required for manufacturing processes.

Performs product and process analysis for cost reduction, quality improvement and improved efficiency.

Utilizing tools associated with risk management (e.g. PFMEA) to identify potential risks and the associated corrective actions.

Supporting required equipment qualification and process validations (IQ, OQ and PQ).

Troubleshoot manufacturing processes when defects occur. Leads investigations to determine root cause and implement effective containment and countermeasures.

Train Engineering and Operations personnel as required on manufacturing processes/equipment.

Disposition non-conforming products and develop re-work procedures.

Leads Kaizen events and drives continuous improvement efforts.

Adhere to the TOMZ Quality Management System.

Perform other duties as assigned.

Minimum of a bachelor’s degree in an engineering discipline or equivalent experience.

Minimum of 5 years’ experience within a regulated industry (preferably in a Medical Device or Aerospace contract Manufacturer).