Senior Manufacturing Software Engineer

Defibtech•Branford, CT

3d•Hybrid

About The Position

Defibtech is seeking a Senior Manufacturing Software Engineer to design and maintain production tools, databases, platforms, and test station software used to manufacture medical devices. These systems are deployed at Defibtech’s Branford, Connecticut site and at contract manufacturers. The role supports new and sustaining products and production-process improvements. It is based onsite at the Branford manufacturing location and is hybrid capable. Software development includes coding, sandbox testing, documentation, writing and executing test protocols, and managing code releases through the Engineering Change process in accordance with quality and regulatory requirements. The role also qualifies test-station environments and databases, supports verification and validation testing, and serves as a central contact for production and pilot test-station setup and troubleshooting. The engineer works with cross-functional teams to transfer development projects into production test environments, supports production investigations and corrective or preventive actions, and creates and manages documentation through Defibtech’s Change Control process. The position promotes continuous improvement and supports compliance with applicable laws, regulations, standards, and company procedures, including FDA requirements, Quality Management Systems Regulations, and safety regulations.

Requirements

Bachelor’s degree in computer science, computer engineering, or a related degree and at least 5 years of relevant experience, or an equivalent combination of education, training, and experience.
Experience with PC hardware, Windows operating systems, and peripherals.
Ability to operate independently, lead manufacturing-related project initiatives, make decisions, influence outcomes, and drive tasks to completion.
Strong written and oral communication skills to accurately convey issues and information.
Ability to multitask and work in a fast-paced, high-volume environment.

Nice To Haves

Experience in a manufacturing or test-support environment.
Experience with embedded software.
Experience with SQL Server, Visual Basic, C#, or similar technologies.
Medical-device product or industry experience, including development under ISO 13485; highly preferred.
Ability to establish and support hardware-platform interfaces and peripheral communications using software applications.

Responsibilities

Support and implement updates to production systems at Defibtech and contract manufacturing sites.
Develop and maintain production tools and systems that interface with Defibtech devices and test equipment, program and test devices, generate labels, and automate test-data recording.
Perform software coding, sandbox testing, documentation, test-protocol writing and execution, and code release management through the Engineering Change process.
Perform test-station environment and database qualifications and support verification and validation testing as required.
Serve as the central contact for production and pilot test-station setup and troubleshooting.
Generate and execute data queries to support production investigations.
Participate in cross-functional teams and facilitate transfer of development projects into the manufacturing production test environment.
Identify and implement improvements to database and software development processes, and develop and implement software for new product rollouts as required.
Support and lead investigations, including root-cause identification and implementation of corrective or preventive actions using processes such as CAPA, PAF, and SCAR.
Create and manage documentation through the Change Control process, including ECR/ECOs, station specifications, documents, and test protocols.
Demonstrate Defibtech’s values and promote and participate in continuous improvement.
Support compliance with applicable laws, regulations, standards, good business practices, and company procedures, including FDA, Quality Management Systems Regulations, and safety requirements.