Senior Manufacturing Software Engineer

Defibtech is seeking a Senior Manufacturing Software Engineer responsible for production tools, databases, platforms, and test station software used in the manufacture of medical devices, which are deployed both on site and at Defibtech’s contract manufacturers. This role is primarily focused on software design and maintenance to support new products, sustain products, and make process improvements to our production tools and systems.

This role is based onsite at our Branford, CT manufacturing location, hybrid capable.

• Supports and implements updates on-site and at contract manufacturing sites to support Defibtech production systems.
• Develops and maintains production tools and systems, which are used to interface with Defibtech devices and test equipment, program and test the devices, generate labels, and automate recording of test data. Software development is inclusive of coding, sandbox testing, documentation, writing and executing test protocols, and managing release of the code through the Engineering Change process, all according to quality and regulatory requirements.
• Performs test station environment and database qualifications and supports verification and validation testing as required.
• Serves as central contact for production and pilot test station setup and troubleshooting.
• Generates and executes data queries in support of production investigations.
• Participates in cross-functional teams and facilitates the transfer of development projects into the manufacturing production test environment.
• Identifies and implements improvements in both database and software development processes and develops and implements new software for new product rollouts, as required.
• Supports and leads investigations, including identification of root cause and implementation of corrective or preventative actions using various Defibtech processes (CAPA, PAF, SCAR, etc.).
• Creates and manages documentation utilizing Defibtech’s Change Control process, including ECR/ECO, station specifications, documents, and test protocols.
• Demonstrates Defibtech’s values on the job. Promotes and participates in continuous improvement.
• Actively supports compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including but not limited to FDA, Quality Management Systems Regulations, safety regulations, and applicable statutes).

• 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.

• Work environment is based within office and light manufacturing setting.
• Light work that includes moving objects up to 20 lbs; frequent sitting, walking, and standing.

• $92,000 - $151,000 per year, depending on experience, qualifications, and other…