Job Description
Job Description
SUMMARY
This position is responsible for the research, design, and development of X-Ray equipment, with a primary focus on the verification and validation (V&V) of system software. The role supports product reliability, regulatory compliance, and customer satisfaction through rigorous software testing and cross-functional collaboration.
ESSENTIAL FUNCTIONS & RESPONSIBILITIES
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Develop system- and subsystem-level software test methods and protocols based on requirements.
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Perform software verification and validation activities in accordance with the design control process.
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Develop automation routines to enhance testing efficiency and accuracy.
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Configure hardware and software in line with test protocols and requirements.
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Complete and maintain accurate and timely design control documentation.
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Lead or support technical investigations and resolution of software-related issues.
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Work cross-functionally with Sales, Customer Service, and Support to ensure customer satisfaction.
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Represent the company at conventions, trade shows, and industry events as needed.
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Provide emergency on-call services in coordination with Service and Support teams.
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Comply with all applicable FSE Guidelines and KMHA policies, including:
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Radiation Safety Policy (badge usage and replacement).
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Corrective Actions Policy procedures.
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Continuously improve through assigned training and development programs.
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Handle additional projects and assignments as directed by management.
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Balance independent work with effective team collaboration.
REQUIREMENTS & QUALIFICATIONS
Education:
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Associate's or Bachelor's degree in Electrical Engineering, Biomedical Engineering, or Computer Science.
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Master's degree is a plus.
Certifications (preferred but not required):
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Certified Radiology Equipment Specialist (CRES) – AAMI
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Certified Biomedical Equipment Technician (CBET)
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Certified Laboratory Equipment Specialist (CLES)
Experience:
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Minimum 3 years of experience in software testing within a regulated industry (e.g., medical devices, automotive, oil & gas).
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Demonstrated ability to write and execute test protocols and reports.
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Hands-on coding experience in one or more programming languages (e.g., C#, C++, Python).
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Ability to read and understand developer-written code.
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Familiarity with DICOM standards and imaging workflows (RIS, PACS, Acquisition).
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Experience with hardware and network setup for lab testing.
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Understanding of medical device system design and design control (ISO 13485, MDSAP).
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X-ray imaging technology experience is a strong advantage.
CORE COMPETENCIES
Technical & Analytical Skills:
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Attention to detail in design and testing.
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Strong problem-solving and analytical thinking.
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Effective project planning and coordination.
Communication & Interpersonal Skills:
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Clear, persuasive oral and written communication.
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Strong presentation and group facilitation abilities.
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Constructive conflict resolution and emotional intelligence.
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Customer-focused attitude with the ability to handle challenging situations diplomatically.
Teamwork & Leadership:
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Works well independently and within teams.
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Supports team goals and contributes to a positive culture.
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Provides and receives feedback effectively.
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Demonstrates confidence and initiative.
Organizational & Time Management:
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Prioritizes and executes tasks efficiently.
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Maintains accuracy under deadlines.
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Meets goals through effective time and resource management.
Quality & Compliance:
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Committed to high-quality work and continuous improvement.
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Follows procedures and maintains detailed records.
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Understands and applies industry regulations and standards.
PHYSICAL REQUIREMENTS
While performing the duties of this role, the employee is regularly required to:
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Sit for extended periods.
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Use hands and arms to operate standard office equipment (e.g., computer, printer, phone).
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Talk and hear in a variety of work environments.
The described physical demands and work environment are representative of those encountered in the role. Reasonable accommodations will be made in accordance with the Americans with Disabilities Act (ADA).