Manufacturing Engineer

TOMZ Corporation; Berlin (CT); On-site; USD 100,000 - 130,000; Full time

Job summary

TOMZ Corporation in Berlin, CT is hiring a Manufacturing Engineer to drive cost-effective manufacturing processes for medical device components. You will lead process development, tool qualification, and continuous improvement initiatives, coordinating with cross-functional teams to launch new products into volume production.

A bachelor's degree in engineering and at least five years in a regulated environment are required, with Lean/Kaizen experience valued.

Qualifications

• Bachelor's degree in engineering or equivalent.
• Minimum 5 years in a regulated industry (Medical Device or Aerospace).
• Ability to read drawings and GD&T.
• Proficiency in SolidWorks and MS Office/Adobe products.
• Knowledge of GMP and ISO 13485 and Lean/Kaizen practices.

Responsibilities

• Support Production to reduce downtime and scrap.
• Conduct tool life studies to drive efficiency and cost savings.
• Perform process capability studies to meet objectives.
• Lead cross-functional teams during production transfer and launch.
• Improve processes for cost reduction, quality, and efficiency.
• Train operations on processes/equipment and manage non-conforming disposition.
• Lead Kaizen events and drive continuous improvement.

Skills

GD&T

SolidWorks

Microsoft Office

Adobe products

GMP ISO 13485

Kaizen Lean

English communication

Education

Bachelor's degree in engineering

Job description

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Manufacturing Engineer

Full Time Berlin, CT, US

9 days ago Requisition ID: 1105

Salary Range: $100,000.00 To $130,000.00 Annually

Join our team in Berlin, CT!!

Summary of Position:

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.

Essential Functions:

• 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.

Qualifications:

• Must possess a 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.

Education:

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

Experience:

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

Preferred Skills:

• Exhibit 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 is needed for managing small to medium products.
• Exposure to oil, grease, dust, metal particles, sparks, 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.