Staff Software/Systems Engineer(Exp In Software Eng, Systems Eng, Medical Device Development) Remote

Position: Staff Software/Systems Engineer (Exp in software eng, systems eng, medical device development & regulatory Industry)

Location: San Diego, CA

Duration: 6 Months

Total Hours/week: 40

1st Shift

Client: Medical Devices Company

Job Category: Engineering

Level of Experience: Senior - Level

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

Job Description:

Job Summary

• 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.

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
• 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.

Minimum Qualifications

• 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 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

• Technical Skills

• 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)