Senior Systems Engineer - Medical Devices
Location : Clifton NJ US 07013
Job Type : Direct
Reference Code : 20966-BZ1
Compensation : 110000.00 - 120000.00 USD/YEAR
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Electrical Engineering
Travel : No
Relocation : No
Job Industry : Medical Devices
Job Description :
- Permanent position for a Senior Systems Engineer for electronics-based medical device manufacturing.:
- Develop and manage risk management files and traceability documentation for electro-mechanical software driven medical devices.
- Serve on engineering and design change teams to define test strategies, identify required risk files, and product specification updates.
- Ensure that sustaining engineering design change activities are compliant with internal and regulatory requirements.
- Risk file management (DFMEA Hazard Analysis, Risk assessment plans, Risk Benefit Analysis, etc.)
- Develop and assist in development of engineering, verification, and validation testing methods and protocols.
Required Qualifications :
- BS Engineering.
- Experience in risk file management (DFMEA Hazard Analysis, Risk Assessment Plans, Risk Benefit Analysis, etc.)
- Ability to generate DFMEAs for complex electro-mechanical software driven medical devices.
- Strong organizational, communication and technical writing skills.
- Strong problem-solving, design, systems-thinking and technical skills.
- Knowledge of Requirements Management Tools such as CaliberRM and DOORS.
- Experience in medical device electronics preferred.