Senior Software Quality Engineer (Medical Device) at Systems Ally
Austin, Texas, USA -
Full Time


Start Date

Immediate

Expiry Date

18 Sep, 25

Salary

120000.0

Posted On

19 Jun, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Working Experience, Management Skills, Iec, Robotics, Medical Devices, Validation, Regulatory Standards, Iso, Jira, Health Insurance, Software

Industry

Information Technology/IT

Description

QUALIFICATIONS

  • BS in an engineering field with an understanding of software, mechanical, and electrical engineering
  • 7 years of experience working in Quality with direct experience in Verification and Validation
  • At least 5 years of experience with medical devices
  • Experience working with robotics preferred.
  • Strong analytical, communication, and time management skills
  • Working knowledge of applicable regulatory standards including but not limited to (21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304)
  • Working Experience with the following tools (preferred): Atlassian Products (Jira, Confluence), Jama, Greenlight Guru, expertise in MS Excel macros, FMEA tool management
  • Working experience with Cybersecurity for Medical Devices is a preferred
  • Intermediate to advanced working knowledge of MS Office suite tools
  • Understanding and working knowledge on various SDLC methodologies including Agile/Scrum
    Job Type: Full-time
    Pay: $120,000.00 per year

Benefits:

  • Health insurance

Compensation Package:

  • Bonus opportunities
  • Stock options

Schedule:

  • 8 hour shift
  • Day shift

Experience:

  • IEC 62304: 7 years (Required)
  • 510k: 7 years (Required)

Work Location: On the roa

Responsibilities

ESSENTIAL DUTIES & RESPONSIBILITIES

  • Review company quality system procedures and work instructions relating to the development, management, control of software and products
  • Monitor and audit software related activities governed by quality management system procedures
  • Review quality specifications and technical design documents to provide timely and meaningful feedback
  • Review and assist software related design documentation including risk management documents and software verification and validation testing protocols, plans, and reports
  • Identify any potential problems that users might encounter
  • Research and analyze product features under test
  • Review user interfaces for consistency and functionality
  • Assist in writing and reviewing product acceptance documentation relating to product software and product interfacing software, as well as software used in the manufacturing, installing, and servicing of the product.
  • Review process software validation protocols and reports for software systems used in support of quality system management operations
  • Experience with requirements analysis and technical design and documentation
  • Working experience with system architecture and engineering
  • Drive progress and collaborate across domains of hardware, software, systems, and regulatory compliance
  • Provide clarification and guidance to teams on the overall quality system with emphasis on design controls
  • Responsible for quality design transfer activities including test method validation/measurement systems analysis and incoming inspection, and process validation.
  • Responsible for assuring departmental compliance with ISO and FDA requirements through supporting internal and external audits.
  • Provide statistical support and expertise and analytical problem solving for product development and manufacturing.
  • Participate in risk management deliverables by facilitating the creation of product design failure modes analysis, and hazard risk analysis and associated deliverables.
  • Participate in cadaveric labs to build understanding of user needs and conduct design validation/usability.
  • Responsible for reviewing product design input/user need traceability
  • Support regulatory pathway determination 510(k) vs Letter to File activities
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