Senior Manufacturing Software Engineer

Defibtech is hiring a Senior Manufacturing Software Engineer for the Branford, CT location (hybrid), supporting medical device manufacturing at the site and through contract manufacturers.

Responsibilities

• Support and implement manufacturing system updates on-site and at contract manufacturing locations to maintain Defibtech production readiness
• Develop and maintain production tools and systems used to interface with Defibtech devices and test equipment
• Build workflows that program and test devices, generate labels, and automate recording of test data
• Perform test station environment and database qualifications
• Support verification and validation testing as required
• Act as the central point of contact for production and pilot test station setup and troubleshooting
• Generate and execute data queries to support production investigations
• Collaborate in cross-functional teams and help transfer development efforts into the manufacturing production test environment
• Identify and implement improvements in database and software development processes
• Develop and implement software for new product rollouts as needed
• Support investigations, including root cause identification and execution of corrective and preventative actions using Defibtech processes such as CAPA, PAF, and SCAR
• Create and manage documentation through Defibtech Change Control, including ECR/ECO, station specifications, documents, and test protocols
• Support compliance of company operations with applicable laws, regulations, standards, and documented procedures (including FDA, Quality Management System Regulations, safety regulations, and applicable statutes)

Requirements

• Bachelor’s degree in computer science, computer engineering, or related degree and at least 5 years of relevant experience, or equivalent combination of education, training, and/or experience
• PC hardware experience, Windows OS experience, and experience with peripherals
• Preferred: Manufacturing or test support environment experience, embedded software experience, and/or SQL Server, Visual Basic, C#, or similar experience
• Highly preferred: Medical Device product/industry experience, including development operating under ISO 13485
• Ability to operate independently, lead project initiatives related to manufacturing, make decisions, influence outcomes, and drive tasks to completion
• Desirable: Ability to establish and support hardware platform interface and peripherals communication using software applications
• 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

Technologies

• Windows OS
• SQL Server
• Visual Basic
• C#
• ISO 13485

Benefits

• Health and wellness benefits
• Company-paid disability & life insurance
• 401k with company matching contribution
• Generous paid time off
• Flexibility for employees to manage time and responsibilities
• Company gatherings to add fun, plus generous paid time off and flexibility for employees to manage time and responsibilities
• Donation programs and time off for volunteerism

Work Environment and Physical Demands

• Office-based work with light manufacturing setting
• Light work including moving objects up to 20 lbs; frequent sitting, walking, and standing

Compensation

$92,000 - $151,000 per year, depending on experience, qualifications, and other job-related factors.