Rate: $150-$200 / hr.

Project Type: Independent Contractor; 10 to 35 hours / week

Education Required: 4-year degree in an engineer field (Biomedical Engineering, Computer Science, Computer Engineering, or Electrical Engineering) or a medical (MD, PharmD, RN) degree

Responsibilities: Quandary Peak Research is looking for a seasoned, smart, and ambitious software quality and medical device professional to assist our tight-knit team of elite software consultants. We provide technical expertise and advice to companies and government agencies on complex regulatory and legal matters involving software.

As a Health IT Quality and Product Safety Consultant assisting our Health IT Team, you will participate in company efforts to evaluate and improve the security of software applications and IT systems. This will include identifying and evaluating compliance with FDA and EU regulations for Quality Systems (QSR), MDR (medical device regulation) and Current Good Manufacturing Practices (CGMPs). You will audit against standards such as ISO 13485, ISO 14971, and similar EU standards.

You will perform research in the emerging Health IT space and apply that knowledge in consultation with private companies (such as EHR vendors, hospitals, medical device companies) and/or the federal government ( such as HHS, ONC, and the OIG).

Project Highlights:

• Assist Health IT, pharma, and medical device companies improve their safety and regulatory posture
• Collaborate with distinguished companies, standards bodies, professors, research institutes, and government agencies
• Become a leader and trusted source of insight in product management, software quality and safety standards for Health IT
• Provide guidance to pharmaceutical, EHR, pharmacy, pharmacy benefit manager (PBM), payer, and medical device companies in meeting and exceeding compliance and regulatory standards
• Assist companies in implementing emerging technologies, including AI and clinical decision support in a manner that meets regulatory requirements
• Continually expand and strengthen your knowledge, skills, and credentials
• Help the public by improving the safety and quality of Health IT and medical device software

Day-to-day activities may include:

• Evaluate compliance with industry standards for software quality management (such as ISO 13485, ISO 9001), risk management standards (such as ISO 14791) and similar
• Make recommendations for improving health IT software safety, usability, reliability, or maintainability based on industry best practices and a thorough understanding of external factors
• Evaluate SDLC and software risk management practices for Health IT, pharma, and medical device companies
• Assist companies in implementing emerging technologies, including artificial intelligence and clinical decision support in a manner that meets regulatory requirements
• Evaluate compliance with FDA regulations for medical devices, hospital systems (including Laboratory Information Systems, PACS systems, and pharmacy/med dispensing systems), drug manufacturing software
• Evaluate ONC certifications and recommendations for EHR software
• Present technical findings and actionable plans to a non-technical audience and answer questions

Work Experience Required: Candidates must have 5+ years of experience as either or both 1) a design engineer, QA engineer, software developer, or product manager for a safety-related and regulated device or IT system, or 2) a medical professional directly involved in the development or configuration of Health IT systems or medical devices for a large hospital or practice group. Relevant experience in Health IT or medical devices (e.g., EHR software) is a big plus. In addition, all candidates should have the following:

• A deep understanding of software safety and quality and risk management fundamentals — both theory and practice
• Experience with user interface design, human factors design and usability in healthcare settings
• Ability to perform compliance-driven technical audits and make insightful, well-formed recommendations for external organizations
• Experience with risk-based and regulated software process development standards (ISO/IEC 62304, ISO 14791), quality management systems (such as ISO 13485, ISO 9001/9003), or quality auditing (ISO 19011)
• Experience applying risk-management and compliance criteria to software development
• A thorough understanding of, and experience with, modern development practices (agile, scrum)
• Exceptional written and verbal communication skills

Preferred Qualifications:

• Professional consulting experience
• Direct responsibility for regulatory compliance or serving in a compliance or auditor role
• A Ph.D. in CS or EE or Clinical training and background (MD, PharmD, RN)
• Professional certifications in quality and risk management or auditing (e.g, ASQ), medical devices/pharma (AAMI, Biopharma Institute), patient safety (IHI), healthcare informatics management (HIMSS, AHIMA), etc.
• Professional experience managing software quality or safety at a regulated device/product company and applying risk-management and compliance criteria to software development
• Research experience in academic or government labs
• Published peer-reviewed papers in academic or industry journals and conferences
• Willingness to travel to New York, San Francisco, Washington DC, Nashville and other US cities

About Quandary Peak Research

Quandary Peak Research was formed in 2012 and has quickly grown to a 25+ member consulting group that provides computer and software expertise to companies, government agencies, inventors, and attorneys, with offices in Los Angeles, Nashville, Austin, Silicon Valley, and New York. Our client list includes companies like Google, Microsoft, Samsung, Nokia, GE, Echostar, and government agencies at the state and federal level. Our recent Health IT clients include major EHR vendors, community hospitals, the ONC, and the OIG. We thrive on unraveling tough technical problems and applying the fundamentals of software engineering to compliance and legal challenges in a trusted, unbiased and professional manner. Visit Health IT and Audits to learn more.

Candidates should send their resume and a brief cover letter to careers@quandarypeak.com