System Engineer 3 -verification and validation DFSS

Pyramid Consulting, Inc; California (MO); On-site; USD 90,000 - 96,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid sick leave

Job summary

Pyramid Consulting, Inc. has an immediate need for a System Engineer 3 specializing in verification and validation DFSS for a 12+ month contract in San Diego, CA onsite. The role focuses on leading system-level engineering across the product lifecycle.

You will drive requirements traceability, risk analyses, and V&V planning, mentor engineers, and apply DFSS methods to medical device projects within a regulated environment; strong cross-functional collaboration is required.

Qualifications

• Systems Engineering experience leading system-level engineering for complex products
• Experience with requirements development, management, and traceability
• Experience planning and overseeing system-level verification and validation activities
• Risk management experience including FMEA and hazard analysis
• DFSS (Design for Six Sigma) experience
• Experience with medical devices or regulated products development

Responsibilities

• Lead system-level engineering activities from concept through launch and sustaining
• Translate customer needs into clear, testable requirements with traceability
• Lead requirements development, management, and traceability across hardware, software, and systems
• Plan and document system-level risk assessments, hazard analyses, and design reviews
• Own verification and validation strategy, planning, coordination, and execution oversight
• Mentor engineers in systems engineering processes and best practices
• Apply DFSS methodologies and drive continuous improvement across projects

Skills

Systems Eng.

Requirements Mgmt

V&V

Risk Management

DFSS

Medical Devices

Regulatory Knowledge

Agile/Hybrid

Technical Leadership

Education

Bachelor's degree in Engineering or related field

Postgraduate degree preferred

Tools

MBSE

Job description

Immediate need for a talented System Engineer 3 -verification and validation DFSS. This is a 12+months contract opportunity with long-term potential and is located in San Deigo, CA(Onsite).

Job ID:26-29806

Pay Range: $65 - $70/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:

• Lead system-level engineering activities throughout the product lifecycle, from concept through launch and sustaining.
• Translate customer and stakeholder needs into clear, testable, and traceable system and product requirements.
• Lead requirements development, management, and traceability activities across complex hardware, software, and integrated systems.
• Plan, facilitate, and document system-level risk assessments, hazard analyses, and design reviews to ensure risks are identified and appropriately mitigated.
• Lead system integration planning and execution, identifying and resolving system-level issues throughout development and sustaining activities.
• Own verification and validation strategy, planning, coordination, execution oversight, and traceability to ensure product requirements are met.
• Develop and execute reliability planning activities and support data-driven product quality improvements.
• Facilitate cross-functional collaboration among Reliability, Statistics, Software, Electrical, Mechanical, Quality, Regulatory, Manufacturing, Clinical, Marketing, and Operations teams.
• Serve as a technical leader on project core teams, helping identify technical risks, resource needs, and critical path activities required to achieve project milestones.
• Investigate and resolve complex system behavior issues, product performance concerns, and technical challenges across development and commercialized products.
• Mentor and guide less experienced engineers in systems engineering processes, tools, and best practices.
• Identify, champion, and implement continuous improvement initiatives to enhance engineering effectiveness, product quality, and development efficiency.
• Apply Design for Six Sigma (DFSS) methodologies and engineering best practices across all projects.

Key Requirements and Technology Experience:

• Key Skills: Systems Engineering Experience – 3–5+ years leading system-level engineering for complex/integrated products through development and launch.
• Requirements Engineering & Traceability – Hands-on experience developing, managing, and tracing system/product requirements.
• Verification & Validation (V&V) – Experience planning, coordinating, and overseeing system-level verification and validation activities.
• Risk Management – Strong experience with FMEA, hazard analysis, risk assessment, and risk mitigation.
• DFSS (Design for Six Sigma)
• Medical Device / Regulated Product Experience – Experience developing medical devices or other regulated products, preferably with design controls and cross-functional product development.
• Bachelor's degree in Engineering, Science, or a related technical discipline. A postgraduate degree is preferred.
• 3-5+ years of relevant engineering experience, or an equivalent combination of advanced education and engineering experience.
• Demonstrated experience leading systems engineering activities for complex products or integrated systems.
• Strong understanding of the product development lifecycle from concept through launch.
• Experience with requirements development, requirements management, and requirements traceability.
• Experience planning and executing system-level verification and validation activities.
• Experience leading risk management activities, including FMEA, hazard analysis, and risk mitigation planning.
• Familiarity with system integration, reliability engineering, design reviews, and technical problem-solving.
• Excellent technical writing, communication, and presentation skills.
• Ability to influence and collaborate effectively across multiple engineering disciplines and business functions.
• Strong analytical, organizational, and problem-solving skills.
• Ability to work independently while providing technical leadership within cross-functional teams.
• Strong attention to detail.
• Experience developing medical devices or products within a regulated industry.
• Experience leading systems engineering efforts on software-enabled or connected products.
• Experience with requirements management tools and model-based systems engineering concepts.
• Experience with statistical methods, Design for Six Sigma (DFSS), reliability engineering, or design optimization techniques.
• Experience driving technical leadership within cross-functional product development teams.
• Experience working in Agile or hybrid product development environments.
• Successful Senior Systems Engineers are recognized as technical leaders who:
• Drive systems thinking across complex product development efforts.
• Influence technical direction through data-driven decision making.
• Proactively identify and mitigate technical risks.
• Build strong cross-functional partnerships.
• Mentor and develop other engineers.
• Champion engineering excellence and continuous improvement.
• Balance customer needs, business objectives, technical feasibility, and regulatory requirements to deliver successful products.

Our client is a leading Medical Equipment Manufacturing Industry, and we are currently interviewing to fill this and other similar contract positions.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.