Job Description

Immediate need for a talented Systems Software Engineer – System Software Analyst . This is a 06+ Months Contract opportunity with long-term potential and is located in San Diego, CA (Remote) . Please review the job description below and contact me ASAP if you are interested.

Job ID:25-60694

Pay Range: $60 - $68.93/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Thoroughly evaluate end-to-end traceability between software design control inputs and/or outputs, and identify gaps or errors; these work items include but are not limited to:
• Inputs: Sources, system requirements, software requirements, software specifications
• Outputs: Test documentation, software code sections, wireframes, etc.
• Remediate the identified gaps or errors by either: correcting errors in traceability, documenting traceability where none currently exists, and/or decomposing (or developing) requirements as needed.
• Evaluate existing test cases and determine any additional testing that is required; if needed, conduct back testing and document accordingly.
• Ensure thorough documentation of all recommended changes and associated rationales
• Develop proficiency in the digital requirements management tool (Polarion) and assist with data migration and population within the tool.
• Incorporate the remediated content to modify and implement software design documents based on updated templates within the Quality Management System.
• Work collaboratively across departments to ensure alignment with additional stakeholders, development teams, and business objectives and to address strategic or feasibility concerns.
• Maintain frequent and clear communication with team members and leaders across the project.
• Identify risks and issues early on; and implement mitigations as necessary.
• Facilitate effective knowledge sharing and collaboration across departments (e.g., Systems Engineering,
• Communicate relevant project information effectively (verbal and written) including project status, technical concepts and design details, and functional demonstrations to key internal and external stakeholders of varying technical abilities.
• Identify and drive opportunities for process improvement within the Software Engineering function to enhance efficiency, quality, clarity, and compliance.
• This is a remote role working with team members primarily based out of either the San Diego or Franklin Lakes offices, or remotely (several in Maryland).
• Most meetings will occur between the hours of 9am – 2pm PST, with some falling before or after that window depending on the time zone of participants.
• Occasional travel to San Diego may be required.

Key Requirements and Technology Experience:

• Skills-IEC 62304 , Composition and decomposition of requirements: Requirement management-analysis and decomposition. (Creating new requirements and/or Modify the existing requirements).
• Traceability.
• FDA reporting.
• Experience in utilizing Polarion software – It’s a big plus.
• Remote – 10% travel required to the office in San Diego, CA.
• Bachelor’s degree or higher in a STEM field is required; postgraduate degree preferred.
• Scrum, Agile, INCOSE certifications are a plus.
• Minimum of 5 years of related work experience in software engineering, systems engineering, medical device development, design control management, and/or similar fields.
• Experience with regulatory standards (e.g., IEC 62304, FDA guidance, IEEE standards) in a regulated industry is highly preferred.
• Experience in Quality engineering and/or project management is a plus
• Leadership-Demonstrated ability to lead multi-disciplinary engineering teams and serve as a technical leader.
• Positive attitude with an aptitude for critical thinking; comfortable in a fast-paced environment.
• Eagerness to learn and adapt to new challenges and technologies; robust problem-solving skills.
• Creative mindset; able to work autonomously and with a group.
• Strong organizational skills; able to handle multiple tasks simultaneously and prioritize workload.
• Strong background in software engineering/product development, including but not limited to:User needs assessment and interpretation/application of regulations and FDA guidance.
• Requirements management, test documentation, and end-to-end traceability.
• Software system analysis and architectural design.
• Failure Modes Effects Analysis and software impacts to risks and mitigations.
• Extensive experience in the creation and maintenance of design and development. documentation is preferred, especially related to requirements and specifications.
• Proficiency in Microsoft applications (Excel, Word, PowerPoint, Outlook, Project, Visio).
• Experience with digitalization tools (Teamcenter, Polarion, SAP, DOORS, ADO, MBSE) is a plus.
• Communication-Strong interpersonal skills, including: collaboration, problem solving, conflict resolution, peer leadership and motivation, etc.
• Exceptional written and oral communication skills in English, both interdepartmental and cross-functional, at all levels of technical expertise.
• Strong writing abilities and attention to detail are essential.
• Authorization to Work-The candidate must be legally authorized to work in the United States without limitations and require no sponsorship for visa status now or in the future (e.g. H1-B status).

Our client is a leading Medical technology Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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