Senior Medical Device Systems Engineer – NPI & Regulation

Sapsol Technologies Inc; Orlando (FL); On-site; USD 90,000 - 130,000; Full time

Job summary

Sapsol Technologies Inc. in Orlando, FL seeks an experienced Systems Engineer to lead the development and release of medical devices in a regulated environment.

You will translate user requirements into design, oversee top-level architecture, and manage risks and design reviews. The role requires extensive systems engineering, regulatory knowledge, and collaboration across disciplines to deliver safe, compliant health care solutions.

Qualifications

• BS degree in engineering.
• Experience leading medical device product development in regulated environments.
• Experience leading groups to solutions for complex problems.
• Experience deriving and simulating user interactions with devices and use conditions.
• Excellent requirements and specification writing skills.
• Demonstrated deep understanding of US and international regulatory requirements for a heavily regulated product.

Responsibilities

• Overall technical leadership and responsibility for realization of a new product release and sustaining activity.
• Translation of user requirements, requirements management, top-level design, feasibility of potential solutions, decomposition of derived requirements.
• Systems design/architecture and integration oversight.
• Support for NPI efforts that create value for Clinical Applications and Devices Organization through innovation and design, while delivering high quality engineering solutions.
• Technical liaison to the program.
• Defect/risk management and design reviews.

Skills

Systems engineering

Regulatory compliance

Requirements management

Cross-functional collaboration

Design reviews

Presentation skills

Risk management

Education

BS degree in engineering

Tools

DOORS

Job description

Sapsol Technologies Inc. in Orlando, FL seeks an experienced Systems Engineer to lead the development and release of medical devices in a regulated environment.

You will translate user requirements into design, oversee top-level architecture, and manage risks and design reviews. The role requires extensive systems engineering, regulatory knowledge, and collaboration across disciplines to deliver safe, compliant health care solutions.