Defibtech, LLC is hiring a Senior Manufacturing Software Engineer for a hybrid role in Branford, CT. Join a team supporting medical device manufacturing with production-ready software tools, test station systems, and compliant documentation. The role offers health and wellness benefits, company-paid disability and life insurance, 401k matching, and generous paid time off, along with flexibility to help employees manage time and responsibilities.
What you’ll do
In this position, you will support and enhance software systems that help Defibtech produce medical devices at the Branford site and at contract manufacturing locations. You will take ownership of software design and maintenance across new product work, sustainment, and process improvement efforts, with responsibilities spanning production tools, databases, platforms, and test station software.
- Support and implement updates on-site and at contract manufacturing sites to maintain Defibtech production systems.
- Develop and maintain production tools and systems used to interface with devices and test equipment, program and test devices, generate labels, and automate recording of test data.
- Perform test station environment and database qualifications and support verification and validation testing as required.
- Act as a central contact for production and pilot test station setup and troubleshooting.
- Generate and execute data queries to support production investigations.
- Work with cross-functional teams to facilitate transfer of development projects into the manufacturing production test environment.
- Identify and implement improvements in database and software development processes and develop new software for product rollouts as required.
- Support and lead investigations by identifying root cause and implementing corrective or preventative actions using processes such as CAPA, PAF, SCAR, and related Defibtech methods.
- Create and manage documentation through Defibtech Change Control, including ECR/ECO, station specifications, documents, and test protocols.
- Support compliance with applicable laws, regulations, and standards, following company documented procedures (including FDA and Quality Management Systems Regulations).
Skills and qualifications
- Bachelor’s degree in computer science, computer engineering, or a related degree, plus at least 5 years of relevant experience, OR an equivalent combination of education, training, and/or experience.
- Experience with PC hardware, Windows OS, and peripherals.
- Preferred: experience in a Manufacturing / Test support environment, embedded software, and/or SQL Server with Visual Basic, C#, or similar technologies.
- Preferred: medical device product/industry experience, including development under ISO 13485.
- Ability to operate independently, lead manufacturing-related project initiatives, make decisions, influence outcomes, and drive tasks to completion.
- Desirable: ability to establish and support hardware platform interface and peripheral communications using software applications.
- Strong written and oral communication skills to convey issues and information accurately.
- Ability to multi-task in a fast-paced, high-volume environment.
Tools you’ll work with
Windows OS, SQL Server, Visual Basic, C#, ISO 13485
Work environment
The work environment is based in an office setting with light manufacturing activities. The work includes light lifting and moving objects up to 20 lbs, with frequent sitting, walking, and standing.
Compensation
$92,000 - $151,000 per year, depending on experience, qualifications, and other job-related factors.
Additional benefits
- Company gatherings
- Donation programs and time off for volunteerism
