PDS Tech Inc Software Engineer in Indianola, Pennsylvania
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.
POSITION DUTIES & RESPONSIBILITIES
• 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.
• 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
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.