Have you managed software requirements? We have a great opportunity for a Software Engineer right outside of Pittsburgh in Indianola, PA. This is a W2 contract role with long term potential. The rate $33/hr., depending on experience?
POSITION SUMMARY 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 Activities • 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.
REQUIREMENTS/PREFERENCES Education Requirement(s): • Bachelor’s degree in Computer Engineering, Electrical Engineering, Electronics Engineering or equivalent. MS is recommended
Preferences: • 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
Please get in touch with us today!
Syndicus NACON provides service-oriented staffing and recruiting services to small businesses, large corporations, nonprofits, and government agencies. We pride ourselves on personal service, local market knowledge and commitment to providing great job opportunities. We specialize in contract, contract-to-hire, and direct placement positions.
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status
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
About Syndicus, Inc.
Companies require specialized resources and technology to stay competitive, compliant and leading edge to solve business challenges and support continued growth. At Syndicus, we create strong relationships and an in-depth understanding of IT staffing and business solutions. We then draw on that collective experience with the goal of helping you fulfill your company’s specific objectives and optimal business strategies.
Syndicus was established in 2007 in Annapolis, Md., as a technical recruiting and staffing company. In 2009, Syndicus expanded its services to include staffing and solutions. Our focus areas for consulting are: Health IT, Life Sciences and Technology Services, especially cyber security resources.
In 2012, we received a full national accreditation from the Electronic Healthcare Network Accreditation Commission (EHNAC) and state designation as a Management Services Organization (MSO) by the Maryland Health Care Commission (MHCC). These noteworthy accomplishments allow us to continue working with healthcare providers on EHR adoption efforts – and subsequent achievement of Meaningful Use.
Today, we provide experienced consultants within our three focus areas ...for organizations across the country. We are a company that values strong relationships, personal connections and investments in our clients’ success. Whether you need staffing or solutions, we work with you to ensure success.