System Engineer

Title: System Engineer

Pay: $60.00-$70.00

Hours: Monday–Friday; 8:00AM–5:00PM

Location: New Kensington, PA 15068 (Hybrid – 3 days onsite, local candidates only)

The System Engineer will lead system-level engineering activities for medical device development, supporting full product lifecycle efforts from concept through verification and validation. This role focuses on system architecture, requirements development, risk management, and cross‑functional integration across software, electrical, and mechanical subsystems. The ideal candidate has strong medical device development experience as a primary system engineer and deep knowledge of industry standards and regulatory requirements.

• Conduct system analysis, modeling, and performance assessments to optimize system performance and mitigate risks
• Lead development of system architecture, requirements, and detailed design specifications
• Write product and element requirements, including rationale and traceability
• Interpret and decompose medical device standards such as IEC 60601-1-11, ISO 80601-2-70, and ISO 80601-2-72
• Lead Failure Mode and Effects Analysis (FMEA) and implement risk mitigation strategies
• Maintain Risk Management Files and Design History Files (DHF) to support regulatory submissions
• Develop system‑level requirements impacting software, electrical, and mechanical subsystems
• Create verification and validation (V&V) protocols, test plans, and traceability matrices
• Collaborate cross‑functionally with R&D, manufacturing, and regulatory teams
• Lead technical reviews and align teams on system requirements and engineering strategies
• Support full New Product Development (NPD) lifecycle activities
• Mentor junior engineers and provide technical leadership on systems engineering initiatives

• Minimum 5 years of systems engineering experience with Bachelor’s degree OR 3 years with Master’s degree
• Hands‑on experience in medical device development as a primary system engineer
• Strong systems engineering knowledge including system architecture, design, and integration
• Experience with electromechanical systems including hardware and software integration
• Expertise with medical device standards such as ISO 14971 and IEC 60601 series
• Experience with requirements development, traceability, and risk management
• Experience developing V-model trace matrices and validation protocols
• Strong cross‑functional collaboration and communication skills
• Experience with New Product Development lifecycle

• INCOSE Certified Systems Engineering Professional (CSEP) certification
• Experience with ISO 80601 standards
• Product lifecycle management and regulatory compliance experience
• Systems modeling, simulation, and performance analysis
• Experience with CI/CD and continuous improvement methodologies

Bachelor’s or Master’s degree in Electrical Engineering, Electronic Engineering, Mechanical Engineering, Computer Science Engineering, or equivalent.

• Health insurance
• Health savings account
• Dental insurance
• Vision insurance
• Flexible spending accounts
• Life insurance
• Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Rate of pay within the stated range will depend on the qualification of the applicant.