Job Listing Description

Software Engineer

PDS Tech, Inc. is seeking a Software Engineer in Indianola, PA

• This position will be responsible to perform software requirements management, verification and validation of medical devices to deliver a high-quality product that meets or exceeds customer expectations and meets FDA design controls.


• Lead and perform functional system analysis, use case development, and software requirements development as design input for software development
• Collaborate with Marketing, System Engineers, and Customers in order to address/elicit customer needs
• Analyze requirements to determine clarity while resolving inconsistency, ambiguity, and contradictions
• Participate in Risk Assessment and develop risk controls
• Verification and Validation of embedded as well as application software for complex system interactions in medical devices
• Develop software verification protocols (manual and automated) for the design and development of the system/subsystem, review requirements, develop test scenarios, review and approve protocols, perform the execution of the protocols, analyzes results, and write reports
• Automating verification protocols for the design and development of the system/subsystem, manages or performs the execution of the protocols, analyzes results, and writes reports.
• Responsible for verification around the various aspects of the software platform of the medical device to account for user interactions, performance, safety and functionality.
• Fulfilling activities to comply with the project deliverables outlined in the Design and Development Plans and Design Control Procedures, as applicable.
• Tracking and document discrepancies, as applicable, during verification.
• Critical analysis of technical situations, identifies problems, and work with the cross-functional team in resolving the problems.
• Effectively collaborates within cross-functional teams across multiple geographies to convey problems, opportunities, solutions and results in the medical device development
• Actively engage in continuous improvement initiatives to establish Center of Excellence (CoE) in Software Assurance function.

Education Requirement(s):
• Bachelor’s degree in Computer Engineering, Electrical Engineering, Electronics Engineering or equivalent. MS is recommended

Skill & Competency Requirements:
• Minimum of 2 years or more of full-time relevant work experience or equivalent in Software Development
• Minimum of 2 years or more of full-time relevant work experience developing and documenting requirements for regulated medical software systems.
• Minimum of 2 years or more of programming experience in any of the following languages C#, Python and C++
• Minimum of 1 year or more of Test Automation experience
• Minimum of 1 year or more experience in all phases of Software Development Lifecycle process using Waterfall and Agile methodology

• Experience designing and developing software for complex systems in a regulated environment while adhering to FDA Design controls and software processes guidelines for medical devices including ISO 13485, ISO 14971, and IEC 62304
• Experience developing software utilizing medical image and radiology standards and technologies including DICOM and HL7.
• Experience working onsite in Hospital/Clinic to work directly with physicians and technologists in order to elicit requirements and feedback and develop new features within software per customer specifications.
• Working knowledge of tools such as Rational Quality Manager, Jenkins, TOSCA, JIRA, Git and DOORS Next Gen
• Working knowledge of scripting languages such as Shell, Groovy, etc
• Working knowledge on OS such as Windows, Linux flavors
• Hands-on experience in DevOps implementation
• Demonstrated ability working in a matrix/hybrid organization structure
• Ability to troubleshoot and make quick knowledge and experience-guided decisions
• Very good written and oral communication as well as strong presentation skills
• Excellent people skills, ability to partner well, good team camaraderie
• Proficient with Microsoft Office tools especially MS Word, MS Excel, MS PowerPoint, MS Project, and other management tools
Job Number: 2110129809
Job Location: Indianola, PA
Duration: 12 months
Input Date: 04/28/2021
Attention: Mike Simmerman
City, State: IRVING, TX 75062
Phone: 214/647-9600
800 Phone: 800/270-4737
Fax Phone: 214/647-9630

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