Systems Engineer

Senior Systems and V&V Engineer responsible for system design, verification, and validation of complex medical devices from concept through commercialization and sustaining lifecycle.

Job Requirements

• Bachelor’s degree in Engineering

• 3+ years of experience in medical device or closely related regulated industry

• Experience with systems engineering and/or verification and validation for complex electro-mechanical or embedded systems

• Ability to work across multiple engineering disciplines (electrical, mechanical, software, pneumatic, materials, wireless, etc.)

• Experience generating and maintaining detailed technical documentation for design and V&V activities

Preferred Skills

• Knowledge of medical device regulations and standards, including design control and risk management (e.g., ISO 13485, ISO 14971, FDA QSR)

• Proficiency with systems engineering and requirements management tools such as DOORS and Polarion

• Experience with data analysis and statistical tools such as Minitab

• Experience supporting sustaining engineering for legacy products and/or new product development in a regulated environment

Job Responsibilities

• Lead or support systems engineering and V&V activities for sustaining legacy products and new product development programs

• Own systems and/or V&V engineering deliverables, including requirements, traceability, protocols, test methods, and reports

• Generate and evaluate technical alternatives to solve system-level problems and mitigate risks

• Develop, execute, and document system-level verification and validation plans, protocols, and test results

• Produce high-quality technical documentation to capture and communicate system designs, architectures, and interfaces

• Use established tools and best practices to collect, analyze, and report product and process metrics related to V&V

• Coordinate with cross-functional teams (R&D, Quality, Regulatory, Manufacturing) to ensure system requirements and V&V activities align with program objectives and regulatory expectations

• Support risk management activities by contributing to hazard analyses, FMEAs, and risk control verification

• Maintain understanding of business, market, and competitive environment to inform system and V&V decisions throughout the product lifecycle

Pay Details: $40.00 to $45.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

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