Systems Engineer II

2 weeks ago

North Haven, United States LanceSoft Full time

JOB DESCRIPTION
Top 3 technical skills that you are required for this role:
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
Experience developing embedded software in C/C++ from requirements
Education Required: Bachelors degree Computer Science
Years Experience Required: Minimum of 5 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
Will the contractor be working 40 hours a week? If not, weekly estimate? Yes
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Hybrid 2 or 3 days in office
What is your timeline for scheduling interviews? January/February
What product line will this person support? Powered Stapling Platform (Signia Stapling System is the current product)

Software Systems Engineer II
Responsibilities may include the following and other duties may be assigned.
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. Articulate major uncertainties associated with software architectures, define risks and opportunities associated with the uncertainties.
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.
Must Have: Minimum 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.
Nice to Have
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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