Senior Systems Engineer
$50 - $60/hour
ApplySenior Systems Engineer
Posted 4 days ago
SENIORITY
Senior
SALARY
$50 - $60/hour
About the role
- Cross-functional coordination across R&D, quality, regulatory, marketing, and manufacturing to translate stakeholder needs into system/product requirements
- Requirements must follow the V-diagram methodology: Inputs (user needs, regs, hazards) → product requirements → product specifications → Build → verification of specifications → verification of Requirements → Design validation
- Ensure complete traceability from user needs through requirements, specifications, to verification/validation for FDA audit readiness
- Lead hazard identification and mitigation (e.g., pinch points, tip-over risks)
- Key Activities:
- Write design verification protocols and reports proving design outputs meet design inputs
- Conduct design validation to confirm the right product was built to meet actual user needs
- Lead feasibility and risk assessments for new product direction decisions
- Facilitate cross-functional problem resolution when requirements aren't met or reliability issues arise
- Drive continuous process improvements and apply DFSS (Design for Six Sigma) best practices
- Create system architecture documentation including block diagrams and system integration plans
- Key Requirements and Technology Experience:
- Bachelor's degree in science/engineering (biomedical, mechanical, or electrical engineering most common); Master's/PhD preferred
- Minimum 5 years as a systems engineer in medical device, aerospace, or defense industries
- Requirements management tools: DOORS, TFS, JIRA, JAMA, Confluence, Polarian, or Cockpit
- Strong requirements traceability experience (not just requirements writing)
- Systems integration and testing expertise (must be well-rounded, not testing-only)
- System architecture planning and design capabilitiesDFSS methodology (design of experiments, root cause analysis, fishbone diagrams)
- Reliability engineering knowledge to collaborate with in-house reliability engineersAI experience for process efficiency improvements in requirements writing, traceability, and hazard management
- Ability to communicate technical details to engineers and business concepts to executives
- Strong writing skills for audit-ready documentation
- Extreme attention to detail (every "I dotted, T crossed" for FDA audits)
- Critical Distinctions
Before you apply
Applying takes about a minute. These four things decide how fast it moves after that.
Your profile is current
It's what we read first. Occupations, seniority and locations matter more than a long history.
Two examples you can talk through
Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.
A number in mind
What you're on now and what would make you move. We negotiate better when we know both.
Your notice period
Employers plan around it, and it's the question that stalls offers most often.
Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.
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