W2 Role :: System Designer :: 100% Remote Job at Stellent IT LLC, Remote

RU9RbW9kT0wxVWRwcEdxRitYUFJTbE9BWUE9PQ==
  • Stellent IT LLC
  • Remote

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

Job Tags

Remote job,

Similar Jobs

Wutherich Company

Data Entry Clerk Fully Remote Job at Wutherich Company

Description The Work From Home Data Entry Clerk is a vital role within our Learning & Development team. As a fully remote position, this role requires a detail-oriented individual who can manage data entry tasks efficiently from the comfort of their own home. The successful... 

BMOC Inc

Multi-Site Property Manager Job at BMOC Inc

 ...Job Title: Multi-Site Property Manager Location: Madison, WI Company: BMOC About Us: BMOC is a reputable property management firm specializing in providing exceptional management services to residential and commercial properties in the Madison area. With a commitment... 

Hotel Emma

Overnight Front Desk Agent - $18 Job at Hotel Emma

 ...visitors, in addition to performing night audit and other relevant overnight Hotel procedures and services. Primary...  ...all pertinent information to the Front Office Manager and Assistant Front...  ...Manager. Report to work for scheduled shift, on time and in accordance with... 

VENTEK Solutions LLC

Mold Setter I Job at VENTEK Solutions LLC

 ...Ventek Solutions in Tullahoma, TN is seeking a Mold Setter I Job Overview: The mold setter will be changing and setting molds and making minor repairs This is a Monday - Friday job for 8 hours per day job and overtime as needed. Key Responsibilities: Changing... 

Sprouts Farmers Market

Vitamin/HBA Manager Job at Sprouts Farmers Market

Job Introduction:Is helping people discover the benefits of supplements and vitamins your desire? Do you enjoy educating and coaching people to a healthier lifestyle? Do you have a passion for delivering an extraordinary customer service experience while working in a fast...