Systems Engineer; medical devices

Position: Systems Engineer (medical devices)
Job-ID Reference
26-00979

Remote
50% Remote Summary The  Systems Engineer will support the overall technical direction of Acute Therapies products. This role involves contributing across the full product development lifecycle—from feasibility to post-market—focusing on requirements management, risk analysis, system integration, and verification/validation within a regulated medical device environment.

Roles & Responsibilities :

Support systems engineering activities across all product lifecycle stages (NPD to post-market)
Translate clinical and user needs into product requirements

Gather and manage requirements from cross-functional inputs (regulatory, quality, manufacturing, service, etc.)Drive system-level design and product realization using engineering best practices

Develop design concepts and research methodologies aligned with business and user needs

Create and maintain Design History File (DHF) documentation

Ensure traceability between requirements, risks, and verification activities

Identify technical risks early and implement mitigation strategies

Perform system integration, verification, and validation activities

Conduct root cause analysis using tools like fishbone diagrams, Pareto charts, etc.

Assess impact of design/process/material changes and recommend solutions

Collaborate and influence cross-functional teams and stakeholders

Ensure compliance with FDA, ISO, and IEC design control standards

Utilize tools/software to support engineering and documentation activities

Required Skills &

Qualifications:

Strong understanding of systems engineering principles

Experience with electro-mechanical and/or software-integrated systems

Knowledge of requirements management and traceability

Familiarity with risk management and reliability engineering

Experience with connected devices / cybersecurity concepts (preferred)
Hands-on with tools such as:

DOORSTeamcenter Track Wise8

JIRA / ALMWorking knowledge of SysML or UMLUnderstanding of statistical methods (DOE, sampling, etc.)Strong analytical, problem-solving, and communication skills

Ability to work independently and manage multiple priorities

Experience in medical devices, especially ICU or kidney care products

Background in regulated industries (medical, aerospace, automotive, military)
Experience working with global, cross-functional teams

Bachelor's or Master's degree in:

Electrical Engineering Mechanical Engineering Biomedical Engineering Software Engineering (or related field)3+ years of relevant experience