Manufacturing Software Engineer – Medical Devices (Hybrid)

Defibtech, LLC; Branford (CT); Hybrid; USD 92,000 - 151,000; Full time

Benefits offered by this job

Health and wellness benefits

Disability insurance

Life insurance

401(k) with company match

Paid time off

Job summary

Defibtech, LLC is seeking a Senior Manufacturing Software Engineer to design and maintain production tools and test station software used in medical device manufacturing. The role combines on-site work at our Branford, CT location with hybrid capability to support contract manufacturers.

You will develop and sustain software for production tools, perform qualifications, and lead cross-functional initiatives to improve data systems and production processes in a regulated environment.

Qualifications

• Bachelor’s degree in computer science, computer engineering, or related degree and at least 5 years of relevant experience OR the equivalent combination of education, training, and/or experience.
• PC hardware, Windows OS, and peripherals experience required.
• Preferred candidates will have experience in a Manufacturing / Test support environment, embedded software, and/or SQL Server, Visual Basic, C# or similar experience.
• Medical Device product/industry experience including development operating under ISO 13485, highly preferred.
• Ability to operate independently, lead project initiatives related to manufacturing, make decisions, influence outcomes, and drive tasks to successful completion.
• Ability to establish and support hardware platform interface and peripherals communication using software applications is desirable.
• Strong written and oral communication skills to accurately convey issues and information.
• Ability to multi-task and work in a fast paced, high-volume environment.

Responsibilities

• Supports and updates on-site and at contract manufacturing sites to support Defibtech production systems.
• Develops and maintains production tools and systems interfacing with Defibtech devices and test equipment.
• Performs test station environment and database qualifications and supports verification and validation testing.
• Serves as central contact for production and pilot test station setup and troubleshooting.
• Generates and executes data queries to support production investigations.
• Participates in cross-functional teams and transfers projects to manufacturing production test environment.
• Identifies and implements improvements in database and software development processes.
• Supports investigations and corrective/preventive actions using CAPA/PAF/SCAR.
• Creates and manages documentation via Change Control (ECR/ECO, station specifications, documents, and test protocols).
• Promotes continuous improvement and aligns with company values.
• Ensures compliance with FDA, QMS regulations, safety standards, and applicable laws.

Skills

Embedded software

SQL Server

C#

Visual Basic

Manufacturing support

Windows OS

Project leadership

Strong communication

Problem solving

Cross-functional teamwork

Education

Bachelor's degree in computer science or computer engineering

Tools

SQL Server

Visual Basic

C#

Job description

Defibtech, LLC is seeking a Senior Manufacturing Software Engineer to design and maintain production tools and test station software used in medical device manufacturing. The role combines on-site work at our Branford, CT location with hybrid capability to support contract manufacturers.

You will develop and sustain software for production tools, perform qualifications, and lead cross-functional initiatives to improve data systems and production processes in a regulated environment.