Dear Job Seeker,
I hope you're doing well.
I am Abida Khan, Technical Recruiter I am reaching out regarding an exciting opportunity for a Systems Engineer – Medical Devices (NPD) position with one of our prestigious Medical Device clients.
We are seeking professionals with experience in Systems Engineering, Medical Device Product Development, FMEA, Risk Management, ISO 14971, IEC/ISO 60601 standards, Verification & Validation (V&V), Requirements Traceability, and electromechanical systems development.
I would love to connect and discuss this opportunity in more detail. If you are interested, please share your updated resume at abida.khan@intellectt.com.
I look forward to hearing from you.
Job Title: Systems Engineer
Location: Pennsylvania
Core Responsibilities
- Develop product, system, and subsystem requirements with rationale.
- Perform FMEA and risk assessments and drive mitigations into requirements.
- Interpret and decompose medical device standards (ISO 14971, IEC/ISO 60601 series).
- Maintain Risk Management File (RMF) and Design History File (DHF).
- Define requirements for software, electrical, and mechanical subsystems.
- Develop Verification & Validation (V&V) plans, protocols, and traceability matrices.
- Lead technical reviews and collaborate with cross-functional teams.
- Support medical device New Product Development (NPD) through the full product lifecycle.
Required Qualifications
- Bachelor’s or Master’s degree in Electrical, Electronics, Mechanical, Computer Science Engineering, or related field.
- 5+ years of experience with a Bachelor’s degree OR 3+ years with a Master’s degree.
- Experience in Systems Architecture, Systems Design, or Hardware Engineering.
- Strong experience in medical device development and electromechanical products.
- Knowledge of ISO 14971 and IEC/ISO 60601 medical device standards.
- Experience with FMEA, DHF, RMF, V&V, and requirements traceability.