Senior Manufacturing Software Engineer - Production Tools

Nihon Kohden North America, Inc.; Branford (CT); Hybrid; USD 92,000 - 151,000; Full time

Benefits offered by this job

Health insurance

401(k) with company matching

Disability & life insurance

Paid time off

Hybrid work capability

Job summary

Defibtech is seeking a Senior Manufacturing Software Engineer to design, update and maintain production tools, test stations, and databases used in medical device manufacturing. The role supports on-site and contract manufacturing environments, with a hybrid work capability in Branford, CT.

You will lead software projects, qualify test environments, write data queries, and ensure compliance with FDA/ISO 13485 while collaborating with cross-functional teams in a fast-paced facility.

Qualifications

• Bachelor’s degree in computer science, computer engineering, or related degree and at least 5 years of relevant experience.
• PC hardware, Windows OS, and peripherals experience required.
• Experience in Manufacturing / Test support, embedded software, and/or SQL Server, Visual Basic, C# desired.
• Medical Device experience including ISO 13485 preferred.
• Ability to operate independently, lead projects, and drive tasks to completion.
• Strong communication skills and ability to thrive in a fast-paced environment.

Responsibilities

• Updates on-site and at contract manufacturers to support production systems.
• Develops and maintains production tools and test interfaces with devices and equipment.
• Performs test station and database qualifications; supports verification and validation.
• Acts as central contact for test station setup and troubleshooting.
• Generates data queries to support production investigations.
• Collaborates in cross-functional teams to deploy projects to production.
• Implements improvements in database/software development for new products.
• Supports CAPA/PAF/SCAR investigations and corrective actions.
• Documents changes via ECR/ECO and change controls.
• Upholds Defibtech values and continuous improvement; ensures regulatory compliance.

Skills

Embedded software

SQL Server

Visual Basic / C#

Manufacturing IT experience

Windows OS

Education

Bachelor’s degree in Computer Science/Engineering

Job description

Defibtech is seeking a Senior Manufacturing Software Engineer to design, update and maintain production tools, test stations, and databases used in medical device manufacturing. The role supports on-site and contract manufacturing environments, with a hybrid work capability in Branford, CT.

You will lead software projects, qualify test environments, write data queries, and ensure compliance with FDA/ISO 13485 while collaborating with cross-functional teams in a fast-paced facility.