> Markdown version of [/jobs/ext/2026486-systems-engineer-ii-iii](https://www.wearedevelopers.com/jobs/ext/2026486-systems-engineer-ii-iii). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md).

---

# Systems Engineer II/III

- **Company:** Planet Pharma
- **Location:** Irvine, CA, United States
- **Contract:** Permanent contract
- **Skills:** Systems Engineering, Software Requirements Analysis, Subsystems, Systems Integration
- **Published:** August 11, 2026
- **Apply:** https://us.experteer.com/career/view-jobs/systems-engineer-ii-iii-irvine-ca-usa-58897920

## About the Role

aau_ system integration * Conduct risk management planning, system risk assessment, use error risk assessments, and design validation * Provide technical leadership and ensure documentation meets safety and regulatory requirements * Facilitate communication across a matrixed organization and manage competing priorities * Contribute to broader application of systems engineering principles within the organization Tasks * Bachelor's degree or higher with equivalent experience; Senior levels require 5-10 years (or 3-7 for Master; 1-4 for PhD per title) * Experience in product development within regulated industries (Medical Device, Pharma, Biotech) * Proven leadership and ability to influence internally and externally * Strong analytical, decision-making, and communication skills * Experience with design and development processes aligned to IEC 60601, ISO 14971, IEC 62304, 11608, 11040, ISO 13485, 21 CFR 820, MDR * Experience in user/stakeholder needs definition, requirements definition, risk
management, and product architecture Key requirements *

## Description

Experteer Overview As a Systems Engineer II/III, you contribute to the development and launch of drug-device combination products within the Device and Combination Product Development - R&D team. You will lead multi-disciplinary integration to ensure patient-centric design and compliant performance. The role emphasizes DHF management, design controls, and risk-based decisions in a regulated environment. You collaborate across engineering teams, influence through a matrixed organization, and provide technical leadership to meet safety and regulatory requirements. This position offers impact at scale by shaping robust, compliant systems for innovative therapies. Compensation / Benefits * Manage DHF and design control documentation to regulatory standards * Lead cross-functional activities: needs definition, use case analysis, traceability, and requirements development * Define system/sub-system requirements and architect integrated solutions * Coordinate third-party development and ensure system integration * Conduct risk management planning, system risk assessment, use error risk assessments, and design validation * Provide technical leadership and ensure documentation meets safety and regulatory requirements * Facilitate communication across a matrixed organization and manage competing priorities * Contribute to broader application of systems engineering principles within the organization Tasks * Bachelor's degree or higher with equivalent experience; Senior levels require 5-10 years (or 3-7 for Master; 1-4 for PhD per title) * Experience in product development within regulated industries (Medical Device, Pharma, Biotech) * Proven leadership and ability to influence internally and externally * Strong analytical, decision-making, and communication skills * Experience with design and development processes aligned to IEC 60601, ISO 14971, IEC 62304, 11608, 11040, ISO 13485, 21 CFR 820, MDR * Experience in user/stakeholder needs definition, requirements definition, risk management, and product architecture Key requirements *


## Related Videos

- [Model Based Systems Engineering in an Agile Product Development Process](https://www.wearedevelopers.com/videos/68-model-based-systems-engineering-in-an-agile-product-development-process)
- [10M Data Records Lost, Underwater Computing, and Psychedelic Fish - Matthias Geniar](https://www.wearedevelopers.com/videos/1908-10m-data-records-lost-underwater-computing-and-psychedelic-fish-matthias-geniar)
- [AI Agents & Agentic AI](https://www.wearedevelopers.com/videos/2017-ai-agents-agentic-ai)
- [Automated Driving - Why is it so hard to introduce](https://www.wearedevelopers.com/videos/628-automated-driving-why-is-it-so-hard-to-introduce)
- [Breaking the Hardware Mindset: Overcoming Barriers to System-Level Innovation](https://www.wearedevelopers.com/videos/1635-breaking-the-hardware-mindset-overcoming-barriers-to-system-level-innovation)
- [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips)

## Related Articles

- [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again)
- [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers)
- [The Ultimate Software Engineer Career Path Guide for 2023](https://www.wearedevelopers.com/magazine/146-the-ultimate-software-engineer-career-path-guide-for-2023)
- [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering)
- [Top-Paying Tech Jobs (with Salaries)](https://www.wearedevelopers.com/magazine/372-top-paying-tech-jobs-with-salaries)
- [What Jobs Can You Get with a Software Engineering Degree?](https://www.wearedevelopers.com/magazine/398-what-jobs-can-you-get-with-a-software-engineering-degree)