Manufacturing Engineer

About the role

Reporting to the Engineering Manager, this position will develop and implement robust, cost-effective manufacturing processes and methods, recommend and improve sustained production processes, and 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.

Responsibilities

• Support Production in reducing or 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.
• Collaborate with cross-functional teams during the production transfer phase to establish and launch robust, mid- to high-volume processes.
• Improve manufacturing processes, methods, and controls for cost reduction, quality improvements, and efficiency for both sustained and new products.
• Prepare engineering change orders and coordinate 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.
• Perform product and process analysis for cost reduction, quality improvement, and improved efficiency.
• Utilize tools associated with risk management (e.g., PFMEA) to identify potential risks and the associated corrective actions.
• Support required equipment qualification and process validations (IQ, OQ, and PQ).
• Troubleshoot manufacturing processes when defects occur. Lead investigations to determine root cause and implement effective containment and countermeasures.
• Train Engineering and Operations personnel as required on manufacturing processes and equipment.
• Disposition non-conforming products and develop re-work procedures.
• Lead Kaizen events and drive continuous improvement efforts.
• Adhere to the TOMZ Quality Management System.
• Perform other duties as assigned.

Requirements

• 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).
• 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.

Preferred Skills

• Good time management skills and ability to prioritize workflow throughout the day.
• Motivated self-starter with ability to work both independently and as part of a team.
• Strong verbal and written English language communication skills.

Physical Requirements

• Ability to bend, stoop, squat, kneel, and lift up to 20 pounds. Team lift or mechanical assistance required for objects over 20 pounds.
• 20/20 vision (assisted or unassisted) required for sorting raw and non-conforming materials.
• Good dexterity needed for managing small to medium products.
• Exposure to oil, grease, dust, metal particles, sparks, and sharp-edged materials. Some exposures may require the use of personal protective equipment or engineering controls.
• Perform keyboard entries with possible frequent operation of a computer.