Medical Device Manufacturing Engineer - Process Excellence

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

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.