Manufacturing Engineer

TOMZ Manufacturing Corp; Berlin (CT); On-site; USD 85,000 - 125,000; Full time

Job summary

TOMZ Manufacturing Corp in Berlin, CT is seeking a Manufacturing Engineer to develop and implement robust cost-effective processes for medical device components. You will lead process capability studies, write work instructions, and coordinate product transfers to high-volume production while partnering with cross-functional teams.

The role requires a bachelor’s degree in engineering and at least 5 years in a regulated environment with GMP/ISO 13485 familiarity.

Qualifications

• Bachelor’s degree in engineering; equivalent experience acceptable.
• Minimum 5 years’ experience in a regulated industry (medical device preferred).
• Experience reading drawings with GD&T; GMP/ISO 13485 knowledge is a plus.

Responsibilities

• Develop and implement robust cost-effective manufacturing processes.
• Perform tool life and process capability studies to drive efficiency.
• Lead product transfers to high-volume production with cross-functional teams.
• Prepare and deploy manufacturing process instructions and work flows.
• Support equipment qualification, IQ/OQ/PQ, and risk management activities.
• Lead Kaizen and continuous improvement events to reduce waste and improve quality.
• Train operations personnel on processes/equipment and procedures.

Skills

Detail oriented

Reading GD&T

English communication

Education

Bachelor's degree in Engineering

Tools

SolidWorks

MS Office

Adobe products

Job description

**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.