Software​/Systems Engineer; Exp in software eng, systems eng, medical device development Remote

Position

Staff Software/Systems Engineer (Experience in software engineering, systems engineering, medical device development & regulatory industry)

San Diego, CA

6 months

40

1st Shift

Medical Devices Company

Engineering

Senior - Level

Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

We are seeking a highly skilled, driven, and experienced Staff Software/Systems Engineer with expertise in developing software design control deliverables that adhere to FDA guidance, regulatory standards within the medical device industry, and the highest level of quality to meet both user and business needs. This role requires a strong technical background in Software Engineering, proven leadership capabilities, and extensive experience in product design and development with a focus on software requirements management.

It is documentation‑centric, and focused entirely on design controls (vs. actual software development or design). The successful candidate will be responsible for remediating software design control items and documentation for accuracy, completeness, and clear upstream and downstream traceability between inputs and outputs. They will operate autonomously and creatively to lead continuous improvement efforts, collaborate across multi‑disciplinary teams, and provide technical expertise to ensure successful project outcomes, in addition to completing the work of software content remediation.

• Thoroughly evaluate end‑to‑end traceability between software design control inputs and/or outputs, and identify gaps or errors; include but are not limited to inputs such as sources, system requirements, software requirements, software specifications.
• Identify outputs including test documentation, software code sections, wireframes, etc.
• Remediate identified gaps or errors by correcting traceability, documenting missing traceability, and/or decomposing or developing requirements as needed.
• Evaluate existing test cases and determine any additional testing required; conduct back testing and document accordingly if needed.
• 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 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 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.
• 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 9 am – 2 pm PST, with some before or after that window depending on participants’ time zones. Occasional travel to San Diego may be required.

• Education
  • Bachelor’s degree or higher in a STEM field is required; postgraduate degree preferred.
  • Scrum, Agile, INCOSE certifications are a plus.
• Experience
  • 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…