Dec 20, 2021

Systems Engineer

  • Orthogonal
  • Remote (Chicago, IL or Remote)
Full time Customer Service Human Factors Quality Regulatory Software

Job Description

We're looking for...

  • Someone who can use Agile working methods to design, implement and execute design control processes for Software as a Medical Device and mobile app/cloud components of connected device systems
  • Someone with a design and engineering mentality. This includes understanding how to design complex systems and sub-systems, and applying design controls when there is a lot of change
  • Someone who will be a key technology and process leader at Orthogonal. You will be intimately involved in almost every aspect of a solution lifecycle, from project inception, engineering design and implementation to maintenance and continuous improvement

Key Tasks for Systems Engineer

  • Design quality processes optimized for frequent releases
  • Active participation in design, development and deployment activities by working closely with Architects, Engineers, Product Managers, Scrum Masters and Project Managers
  • Curate traits of quality in the culture of Software as a Medical Device development at Orthogonal
  • Contribute to translating and articulating user or stakeholder needs into an engineering requirement
  • Lead Risk Management, Design Assurance, Design Verification, Design Reviews and Reliability Planning activities
  • Develop, manage and maintain design history files and related deliverables
  • Maintain up-to-date knowledge of medical devices, technologies and the regulatory landscape related to the company’s products

Preferences

  • BS or MS in Bioengineering, Biomedical Engineering, Computer Science or a closely related field
  • Understanding of risk analysis, risk management, software safety classifications and software segregation
  • Skilled at QMS with a strong awareness for what constitutes a design history file or medical device software. Should be able to speak to: requirements, configuration, usability, testing and risk
  • Familiarity with SaMD/software-only medical device development
  • Strong interpersonal, communication, oral and written skills
  • Must be confident and capable in a client-facing role
  • An understanding of ISO 13485, ISO 14971 and IEC 62304 and how to apply them to software for a medical device (or similar standards in other regulated industries) is required

Benefits

  • Medical, dental, and vision insurance
  • 401k & 401k matching (up to 3%)
  • Remote and in-office work options available
  • 22 PTO Days and 10 paid company holidays annually
  • Flexible work schedule
  • Strong work-life balance

Apply Now