> Markdown version of [/jobs/ext/585116-system-engineer](https://www.wearedevelopers.com/jobs/ext/585116-system-engineer). 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). --- # System Engineer - **Company:** ComTec - **Location:** New Kensington, PA, United States - **Experience:** Experienced - **Salary:** $135,200.0 - $174,720.0 - **Contract:** Temporary contract - **Skills:** Systems Engineering, Failure Mode Effects Analysis, Systems Architecture, Systems Integration - **Published:** June 18, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=16c4b7d5488b5390 ## About the Role Do you have experience in Systems integration?, We are seeking a hands-on Systems Engineer with direct medical device new product development experience who has served as a primary systems lead-not solely in a quality or support capacity. The ideal candidate will be a broad technical systems thinker with demonstrated ownership of system architecture, risk management, and standards compliance throughout the full product lifecycle. Candidates must have recent medical device industry experience and a stable employment history reflecting sustained contributions to device development programs., * Bachelor's or Master's degree in Electrical, Mechanical, Computer, or Systems Engineering (or equivalent). * Minimum 5+ years of hands-on medical device systems engineering experience. * Demonstrated experience leading New Product Development (NPD) programs through full product lifecycle. * Strong background in systems architecture, requirements engineering, and cross-disciplinary integration. * Proven expertise in: * ISO 14971 Risk Management * IEC 60601 and ISO 80601 standards * FMEA leadership * V-Model development and traceability * Experience developing electromechanical medical devices integrating hardware and software. Preferred Qualifications * INCOSE Certified Systems Engineering Professional (CSEP) certification. * Experience serving as primary Systems Engineer on commercialized devices. * Experience supporting regulatory submissions and audit readiness. * Exposure to model-based systems engineering (MBSE) tools. RAM#, * Medical Device: 5 years (Preferred) * New Product Development: 5 years (Preferred) * Systems engineering: 4 years (Preferred) License/Certification: * CSEP (Preferred) Work Location: Hybrid remote in New Kensington, PA 15068 ## Description * Lead end-to-end systems engineering activities for medical device new product development programs. * Develop and document Product and Element Requirements with clear technical rationales. * Perform standards decomposition of IEC 60601-1-11, ISO 80601-2-70, ISO 80601-2-72, translating regulatory requirements into actionable subsystem requirements. * Lead deep-dive FMEA activities and system-level risk management (ISO 14971). * Ensure all risk controls and mitigations are properly documented within the Risk Management File (RMF) and Design History File (DHF). * Develop and maintain traceability matrices across the V-model, ensuring bidirectional requirement flow-down and verification alignment. * Define how system-level risks propagate into software, electrical, and mechanical subsystem requirements. * Develop comprehensive Verification & Validation (V&V) strategies, protocols, and test plans. * Serve as technical lead across R&D, manufacturing, regulatory, and quality teams to drive alignment. * Mentor junior engineers in systems methodology and best practices. ## 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) - [The QUEST for Better Software](https://www.wearedevelopers.com/videos/721-the-quest-for-better-software) - [Physical AI: The Era of Intelligent Machines](https://www.wearedevelopers.com/videos/100141-physical-ai-the-era-of-intelligent-machines) - [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) - [The Software Engineer 2030: From Coder To AI Orchestrator? - Patrick Schnell](https://www.wearedevelopers.com/videos/1825-the-software-engineer-2030-from-coder-to-ai-orchestrator-patrick-schnell) - [Exploring Durable Execution with Python](https://www.wearedevelopers.com/videos/1234-exploring-durable-execution-with-python) ## Related Articles - [Where To Find Software Engineering Jobs](https://www.wearedevelopers.com/magazine/396-where-to-find-software-engineering-jobs) - [Where to Find Entry-Level Software Engineering Jobs](https://www.wearedevelopers.com/magazine/397-where-to-find-entry-level-software-engineering-jobs) - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [Is Software Engineering Over-Saturated?](https://www.wearedevelopers.com/magazine/418-is-software-engineering-over-saturated) - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers) - [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering)