System Engineer

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

Pls share Candidates from Medical Devices Testing companies.

Job Description:

• 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

You are a part of:

A team of highly skilled engineers that is focused on creating world class health care solutions. Our focus on improving lives contributes to our amazing work environment and culture.

To succeed in this role, you should have the following skills and experience:

• BS degree in engineering


• Experience leading medical, or other regulated industry, product development


• Experience in leading groups to solutions for complex problems


• Experience with deriving and simulating human interactions with devices and device use conditions


• Experience with electronic requirement data management SW – preferably DOORS


• Minimum five years engineering / R&D experience in a rigorous quality-focused environment


• Minimum three years’ experience in a Systems Engineering role, or a role having overall systems responsibility involving electrical (analog and digital), mechanical, firmware and software development disciplines


• Excellent requirements and specification writing skills


• Demonstrated deep understanding of US and international regulatory requirements for a heavily regulated product


• Ability to build and maintain effective cross-functional and cross-organizational relationships


• Excellent oral, written and presentation skills


• In depth knowledge performing risk management per ISO 14971


• In depth knowledge in developing and testing products to IEC60601-1 Safety standard


• In depth knowledge in developing and testing products to IEC62336 EMC standard

Preferred Requirements

• Understanding of US and international regulatory requirements for medical devices strongly preferred


• Experience developing reliability plans


• Knowledge of product development processes and best practices


• Knowledge of verification and validation testing processes


• Electrical or Software development experience is a plus


• Master’s degree preferred