W2 Role :: System Designer :: 100% Remote

Overview

Full Time
Accepts corp to corp applications
Contract - Independent
Contract - W2
Contract - Long Term

Skills

Systems Design
Medical Devices
FOCUS
Software Testing
Report Writing
JIRA
Technical Writing
Creative Problem Solving
Reporting
Management
Technical Drafting
System Requirements
Traceability Matrix
Documentation
Risk Management
Risk Analysis
Usability
ISO 9000
Testing
Product Development
Communication
Collaboration
Research and Development
Quality Assurance
LinkedIn
Oracle UCM

Job Details

Job Title System Designer

Location 100% Remote

Duration Long Term Contract
Only for W2

Job Description

System Design risk management, FMEAs, usability, verification testing, test protocols, and QA

We are seeking experienced professionals for a long-term contract opportunity focused on risk file creation and software testing within the medical device industry. This role requires a balance of technical expertise and strong communication skills.

Key Focus Areas:

  • Risk file creation, including UFMEA, risk control measures, and risk file linkages
  • Software testing activities such as QA, protocol/report writing, and JIRA issue closure
  • Design validation protocol development and validation method creation

Candidate Profile:

  • Strong technical writing and documentation skills
  • Experience with protocol review, technical review, and creative problem-solving
  • Background in clinical, quality, or regulatory areas is highly valued, particularly for validation work
  • Previous design validation experience preferred
  • Excellent communication skills for providing clear status updates and reporting issues
  • Ability to work independently, demonstrate initiative, and manage workload effectively

Below are the key skills we're looking for in this role:

  • Documentation: Experience drafting and maintaining DHF content, including user needs, system requirements, design inputs, traceability matrices, and risk documentation.
  • Risk Management & Usability: Able to support risk analysis (e.g uFMEA etc) and contribute to usability planning and design mitigations. Familiar with ISO 14971 (required) and IEC 62366 (preferred).
  • Testing: Ability to define testable requirements, support V&V protocol development, and ensure traceability in collaboration with the Product Development team.
  • Cross-Functional Communication: Strong collaboration skills across R&D, QA, clinical, and regulatory functions; able to clearly translate technical information across stakeholders.

Akshit Sisonia - Sr. Technical Recruiter

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