Software Systems Engineer II

12 hours ago


New Haven, Connecticut, United States LanceSoft Full time
Job Description

LanceSoft is seeking a highly skilled Software Systems Engineer II to join our team. As a key member of our software engineering team, you will be responsible for designing, developing, and deploying software systems that meet the needs of our customers.

Key Responsibilities:

  • Act as the software systems engineer on assigned programs and support the Software Engineering SME on projects throughout the project life cycle phases.
  • Collaborate with cross-functional NPD and Business Portfolio team members to integrate and deploy systems engineering methodologies.
  • Lead the definition, development, and management of software requirements, software architecture, interfaces, and software test integration protocols.
  • Identify and retire risks related to NPD projects to improve quality, predictability, and performance.
  • Work with program core team members including Quality and Regulatory to ensure conformance to established design development processes and procedures.
  • Assist in the identification and implementation of Systems Engineering process improvements.
  • Work with the various engineering disciplines to translate market-driven requirements into technical specifications, and ultimately flow them down into lower-level software, and firmware requirements documents.
  • Partners with Design Quality to lead FMEA and risk analysis discussions at all levels to ensure product quality and reliability.
  • Support functional process and tool improvement initiatives by being early adopter of ideas on projects without impacting project schedules.
  • Possess a strong understanding of functional and customer requirements and be capable of effectively teaching and mentoring others on how to develop, write, and manage requirements.
  • Function well in a team environment. Gains consensus, leads, influences, and ensures cross-functional participation and feedback.
  • Demonstrates good design practices and methodologies.

Requirements:

  • Bachelors degree required. Minimum of 5 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
  • Experience as a system engineer for software development of a medical device from concept phase, proof of design testing, development, V&V, certification, and launch.
  • Demonstrated proficiency in developing system architecture for complex systems.
  • Demonstrated proficiency in requirements flow down, allocation and management.
  • Understanding of medical devices and hospital connectivity and interoperability.
  • Experience developing technical frameworks and architectures that support changing system functionality, components, performance, or interfaces.
  • Experience in product development through a traditional software engineering discipline.
  • Experience in risk management.
  • Experience in applying regulatory standards to products (IEC 62304, DO-178C,).
  • Familiarity with FDA Quality Systems Regulations (QSR) preferred.
  • Experience developing embedded software in C/C++ from requirements.
  • Experience developing desktop applications from requirements.
  • Experience with Integrity Requirements Management Tool.
  • Experience using Git, Bitbucket, and Jira.


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