Job Title: System Engineer
Location: New Kensington, PA (Hybrid)
Job Summary: We are seeking a highly skilled professional to drive continuous improvement across systems engineering operations. Our team values individuals who thrive in cross-functional environments and are committed to delivering robust electromechanical solutions in alignment with industry standards.
Responsibilities:
- Conduct advanced system analyses and performance assessments, utilizing modeling and simulation techniques to identify opportunities for improvement and risk mitigation.
- Bridge communication between R&D, manufacturing, and regulatory affairs to ensure alignment on systems engineering requirements and standards.
- Review system documentation and design artifacts to verify compliance with established engineering principles and regulatory guidelines.
- Lead and execute comprehensive strategies, including deep-dive FMEA, requirements writing, traceability matrices, and technical reviews that drive process enhancements and continuous improvement.
Experience/Minimum Requirements:
- Bachelor’s or master’s degree in Electrical Engineering, Electronic Engineering, Mechanical Engineering, Computer Science Engineering, or equivalent.
- Minimum of 5 years of relevant experience with a bachelor’s degree, or minimum of 3 years with a master’s degree, in areas such as system architecture, design, and hardware engineering.
- Demonstrated expertise in new product development, working across the full product life cycle, and developing electromechanical devices with hardware and software elements.
- Deep understanding of medical device standards, including ISO 14971 and the IEC 60601 series, and proficiency in requirements management, risk assessment, and continuous improvement processes.
About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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