Senior Manufacturing Software Engineer

Defibtech, LLC; Branford (CT); Hybrid; USD 92,000 - 151,000; Full time

Benefits offered by this job

Health and wellness benefits

Disability insurance

Life insurance

401(k) with company match

Paid time off

Job summary

Defibtech, LLC is seeking a Senior Manufacturing Software Engineer to design and maintain production tools and test station software used in medical device manufacturing. The role combines on-site work at our Branford, CT location with hybrid capability to support contract manufacturers.

You will develop and sustain software for production tools, perform qualifications, and lead cross-functional initiatives to improve data systems and production processes in a regulated environment.

Qualifications

• 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.

Responsibilities

• Supports and updates on-site and at contract manufacturing sites to support Defibtech production systems.
• Develops and maintains production tools and systems interfacing with Defibtech devices and test equipment.
• Performs test station environment and database qualifications and supports verification and validation testing.
• Serves as central contact for production and pilot test station setup and troubleshooting.
• Generates and executes data queries to support production investigations.
• Participates in cross-functional teams and transfers projects to manufacturing production test environment.
• Identifies and implements improvements in database and software development processes.
• Supports investigations and corrective/preventive actions using CAPA/PAF/SCAR.
• Creates and manages documentation via Change Control (ECR/ECO, station specifications, documents, and test protocols).
• Promotes continuous improvement and aligns with company values.
• Ensures compliance with FDA, QMS regulations, safety standards, and applicable laws.

Skills

Embedded software

SQL Server

C#

Visual Basic

Manufacturing support

Windows OS

Project leadership

Strong communication

Problem solving

Cross-functional teamwork

Education

Bachelor's degree in computer science or computer engineering

Tools

SQL Server

Visual Basic

C#

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.
• 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.

Defibtech is committed to a diverse workplace and is an Equal Opportunity/Affirmative Action employer and E-Verify Company. We provide fair and equal employment and advancement opportunities for all employees and candidates regardless of race, color, religion, national origin, gender, sexual orientation, age, marital status, disability, protected veteran status or any other status protected by federal, state, or local law.

All offers of employment are contingent upon the successful completion of a background check, drug screen, verification of legal right to work in the U.S., and in some cases, a credit check. A credit check will be administered when a prospective employee will be working in Finance, or where duties may involve handling of funds, accounts, or cash. A Motor Vehicle (MVR) check will be administered when a prospective employee will be regularly driving on Company business.

Defibtech endeavors to make www.defibtech.com accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact Human Resources at 203.453.6654. This contact information is for accommodation requests only and should not be used to inquire about the status of applications.