Systems Engineer (Medical Devices) (FL)

Cedent Consulting Inc; Orlando (FL); On-site; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a System Engineer to provide technical leadership in developing innovative medical devices. In this dynamic role, you will be responsible for managing requirements, defining system architecture, and overseeing hardware/software integration. The ideal candidate will have a strong background in medical device development, with over 10 years of experience and a solid understanding of relevant standards. This contract position offers the chance to work closely with customers and lead product development from concept to production, making a significant impact in a fast-paced environment. If you possess critical thinking skills and a passion for medical technology, this opportunity is perfect for you.

Qualifications

• 10+ years of experience in medical device development required.
• Strong knowledge of IEC 60601 or ISO 11608 standards.

Responsibilities

• Manage requirements and develop system architecture for medical devices.
• Lead HW/SW integration and prototype build activities.

Skills

Critical Thinking

Decision Making

Communication

Medical Device Standards Knowledge

Education

BS in Mechanical Engineering

BS in Electrical Engineering

BS in Software Engineering

BS in Biomedical Engineering

Tools

Modern Requirements

APIS

MatLab

Simulink

Job description

The System Engineer will provide technical leadership and oversight for the development of new medical devices developed in conjunction with our client's customer partners in a fast-paced environment. The System Engineer will develop systems engineering deliverables such as requirements, product architecture, and risk analysis and be a key team member working closely with the customer’s team. The ideal candidate will have a successful track record of leading technical product
development teams and launching products into production.

Job Responsibilities

1. Requirements management and development
2. System architecture definition including interface definition and interaction diagrams
3. Concept Development including evaluation and selection
4. Technology / key component selection
5. Oversee HW/SW integration
6. Work with product verification team for test method development
7. Participate in prototype build activities
8. Root cause investigation of technical issues
9. Be customer facing and interface with the customer’s technical team

Required Expertise

1. Solid critical thinking and decision-making skills
2. Ability to work closely with the project manager and drive action within the team
3. Clearly communicate complex information especially with the management team
4. Knowledge of the medical device standards and regulations such as IEC 60601 or ISO 11608

Desired Skills

1. Experience with using Modern Requirements or similar requirements management tools
2. Experience with using APIS or similar DFMEA tools
3. Experience with MatLab / Simulink

Education and Work History Requirements

1. BS in ME, EE, SW, or Biomedical engineering is required
2. At least 10+ years of relevant experience in medical device development
3. Experience managing entire design cycles from concept to production

This is a contract position.