Job Description

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

Email - akshit@stellentit.com

LinkedIn - linkedin.com/in/akshit-s-97297125a

STELLENT IT A Nationally Recognized Minority Certified Enterprise

" Happiness can be found, even in the darkest of times, if one only remembers to turn on the light ."
- JK Rowling

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