Systems Engineer III

Company Info
Apple & Associates
Chapin, SC, United States

Phone: 330-265-7231
Web Site:

Company Profile


Systems Engineer III


Irvine, CA 



Job ID:


Job Description:

Systems Engineer III
Our client, a privately held medical device start-up company preparing for a new innovative launch in 2022, is currently seeking a Systems Engineer III  (II or III) for their Irvine, CA office. 

The purpose of the Systems Engineer is to design, build, test and verify the entire system including SW, FW, Electrical, Mechanical,  and Controllers for a smart, portable medical device with motors, pumps, valves, liquid handling, and measurement functions.

We are looking for an experienced engineer who comes from a highly regulated industry (medical device preferred) with knowledge of full system verification with systems including fluidics or something similar.  We may consider hiring a Systems Engineer who has experience on systems without fluidics or with candidates that have done some verification and testing but not the entire system.

Systems Engineer III Responsibilities:
  • Models systems behavior to drive architectural decisions and requirements definition and refinement.
  • Provides links between design inputs, architectural components and subsystem requirements, to ensure design meets expectations.
  • Determine patient and user requirements for the medical devices we are developing
  • Responsible for system to sub-system architecture decomposition and design
  • Responsible for product documentation deliverables including – Product Requirement Specification, System Architecture Document, System Hazard Analysis, Failure Modes and Effects Analysis
  • Plans and coordinates cross-functional dependencies, including integration
  • Plans and coordinates system level test activities
  • Facilitates resolution of cross-functional issue
Systems Engineer III Qualification Requirements:
  • BSc degree in Engineering
  • Minimum of 7 years of product development experience with a preference for at least five years in medical product development (or other highly regulated industry), or Graduate Degree with 5 years of product development experience with at least 3 years in medical product development (or highly regulated industry, such as Aerospace, Military, DOD or Automotive Systems)
Systems Engineer III Experience and Required Skills:
  • Systems engineering experience spanning the entire product life-cycle, including proficient use of systems engineering tools (e.g. requirements management, change control, traceability analysis etc).
  • Knowledge and experience architecting control systems
  • Previous experience with programmable electromechanical medical or regulated products is required
  • Experience managing small teams (internal and external) required
  • Experience with Human Factors and Usability Assessments a plus
  • Demonstrated experience with facilitating cross-functional trade-offs
  • Good documentation skills
  • Demonstrated ability to work on problems of a complex scope where analysis of situations or data involves multiple competing factors
Systems Engineer III Knowledge and Abilities:
  • Product development life-cycle knowledge is required
  • Understanding of Medical Device design control process is desired (ISO 13485, FDA CFR 820)
  • Familiarity with medical device test standards (60601-1, 6214971 & 62304)
  • Works well with other engineers in a collaborative, fast-paced goal-driven environment