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

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