Bachelor's degree in computer science, computer engineering, or related field with 5+ years of relevant experience or equivalent education and training.
Experience with PC hardware, Windows OS, and peripherals is required.
Preferred experience in Manufacturing/Test support, embedded software, SQL Server, Visual Basic, or C#.
Medical Device industry experience, particularly under ISO 13485, is highly preferred.
Strong ability to operate independently and lead manufacturing project initiatives.
Excellent written and oral communication skills for effective issue conveyance.
Ability to multi-task in a fast-paced, high-volume environment.
Responsibilities
Support and implement updates for production systems at both on-site and contract manufacturing locations.
Develop and maintain production tools and systems for device interfacing, programming, testing, and data automation.
Perform qualifications for test station environments and databases, supporting verification and validation testing as needed.
Act as the central contact for setup and troubleshooting of production and pilot test stations.
Generate and execute data queries to support production investigations.
Participate in cross-functional teams to facilitate project transfers into manufacturing environments.
Identify and implement improvements in software and database development processes.
Benefits
Comprehensive health and wellness benefits, including company-paid disability and life insurance.
401k plan with company matching contributions.
Supportive work culture that emphasizes collaboration and values.
Generous paid time off and flexibility for work-life balance.
Opportunities for philanthropic engagement through donation programs and volunteer time off.
Full Job Description
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.
Core Responsibilities:
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).
Qualifications / Requirements:
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 and Physical Demands:
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.
Compensation:
$92,000 - $151,000 per year, depending on experience, qualifications, and other job-related factors.
Benefits:
Defibtech offers a comprehensive benefits package including health and wellness benefits, company-paid disability & life insurance, and 401k with company matching contribution and more.
Defibtech promotes a challenging, collaborative, and friendly culture that is centered around our values and mission.
Defibtech is supportive of work balance, providing company gatherings to add fun and generous paid time off and flexibility for employees to manage time and responsibilities.
Defibtech is committed to empowering and supporting our employees in their philanthropic efforts through donation programs and time off for volunteerism.
The above description of core responsibilities and qualifications is intended to describe the general nature and level of the work being performed, but they are not an exhaustive list of all the required responsibilities and skills of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
About Nihon Kohden
Nihon Kohden is a Japanese manufacturer, developer and distributor of medical electronic equipment, with subsidiaries in the United States, Europe and Asia. The company's products include patient monitors, electroencephalographs (EEGs), electromyographs (EMGs), electrocardiographs (ECGs), defibrillators, and hematology analyzers. Nihon Kohden's products are used in hospitals, clinics, and other healthcare facilities around the world. The company was founded in 1951 and is headquartered in Tokyo, Japan.
