Job Description

Dear job seeker,

I hope you're doing well.

I am Abida Khan, recruiter from Intellectt Inc. regarding an exciting job opportunity for a Systems Engineer position based in New Kensington, PA (Hybrid 3 Days Onsite) with one of our prestigious medical device clients.

I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at abida.khan@intellectt.com .

Job Title: Systems Engineer

Location: New Kensington, PA

Duration: 12 Months Contract

Job Summary

We are seeking an experienced Systems Engineer to support the development of medical devices throughout the product development lifecycle. The ideal candidate will have expertise in systems engineering, requirements management, risk analysis, and medical device standards.

Core Responsibilities

• Lead system architecture, system design, and requirements development for complex medical device products.
• Perform requirements decomposition, traceability, and allocation across software, electrical, and mechanical subsystems.
• Conduct FMEA, hazard analysis, and risk management activities in accordance with medical device regulations.
• Develop and maintain verification & validation (V&V) plans, protocols, and test strategies.
• Interpret and apply medical device standards, including IEC 60601 and ISO 14971, to product development activities.
• Collaborate with cross-functional teams including R&D, Quality, Regulatory Affairs, Manufacturing, and Software Engineering throughout the NPD lifecycle.

Required Qualifications

• Bachelor's or Master's Degree in Electrical Engineering, Mechanical Engineering, Computer Science, Systems Engineering, or a related field.
• Minimum 5+ years of experience (Bachelor's) or 3+ years (Master's) in System Architecture, System Design, Hardware Engineering, or related areas.
• Experience developing electromechanical products with both hardware and software components.
• Strong knowledge of Medical Device Standards (ISO 14971, IEC 60601 Series), Risk Management, FMEA, and Requirements Engineering.

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