Senior Software Requirements and Systems Engineer

Advantage Technical is hiring in your area! We are seeking a highly motivated Senior Software Requirements and Systems Engineer to join our dynamic team in the San Diego, CA area.

Schedule + Pay

• Hybrid schedule (Must be able to commute to the San Diego, CA office)
• $87 per hour

Qualifications

Education

• Bachelor's degree in systems, biomedical, electrical, computer engineering/science, or a related field-or equivalent experience.

Experience

• 5+ years contributing to complex, safety-critical, or regulated products (medical device experience preferred; aerospace, automotive, rail, or industrial safety acceptable).

Skills/Knowledge

• Proven expertise in software/system requirements writing and management with strong decomposition, clarity, and testability.
• Knowledge of systems engineering practices, risk analysis, and software/system architecture concepts.
• Experience operating under a QMS/design controls and collaborating across Software, Systems, V&V, Quality, and Product teams.
• Proficiency with ALM tools (Polarion, Helix ALM, DOORS) and traceability methods.
• Comfortable in Agile environments, aligning the Definition of Ready/Done with regulatory requirements.
• Exceptional facilitation, documentation, and stakeholder communication skills.

Preferred Qualifications

• Familiarity with medical device standards: IEC 62304, ISO 14971, ISO 13485, 21 CFR 820.30.
• Certifications in Systems or Requirements Engineering (INCOSE, IREB/CPRE).
• Experience with diabetes management products, IoT/mobile/cloud, cybersecurity/privacy compliance (GDPR).
• PLM change control experience.
• Knowledge of analogous safety standards (DO-178C, ISO 26262, IEC 61508) with willingness to map to IEC 62304.

Key Responsibilities:

• Elicit, document, and refine clear, testable software requirements from user needs and product specifications.
• Facilitate technical reviews with cross-functional stakeholders to drive alignment and decision-making.
• Build and maintain bidirectional traceability across user needs, hazards/risks, software requirements, design/architecture, and verification per IEC 62304 and ISO 14971.
• Generate traceability reports for regulatory submissions and audits.
• Manage requirements in ALM/PLM tools (e.g., Polarion, Helix ALM, DOORS + PLM), including versioning and baselining.
• Review downstream artifacts (architecture, DFMEA/FMEA, test strategies) to ensure requirements are implemented correctly.
• Partner with Product Owners to translate requirements into Agile user stories with actionable acceptance criteria.
• Drive continuous improvement of requirements engineering practices, templates, and tool workflows.

Employee Benefits:

• Medical, dental, vision, and pet insurance
• 401(k) Retirement Savings Plans
• Employee Assistance Program (EAP)
• Commuter/Parking Accounts
• People Perks
• Health Savings Account (HSA)
• AD & D Insurance

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With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit AdvantageTechnical.com.

Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact your local branch. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

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