Iso 13485 Developer Jobs

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Senior Manufacturing Software Engineer

Defibtech, LLC Branford, CT

Branford, CT

Today

$92k - $151k/yr Full time Senior .NET Data Processing

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Job Description

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.

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