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Form of workReality Labs is seeking an experienced Medical Devices design controls professional to lead the establishment of software development lifecycle, cybersecurity, and risk management processes for the organization working on Software as a Medical Device (SaMD). This subject matter expert will work cross functionally throughout the organization to champion the adoption of processes that compy to FDA regulations. The ideal candidate will act as an internal consultant and have deep domain experience in software as a medical device development using the principles and requirements from 21 CFR 820, ISO 13485, ISO 14971, IEC 62304, etc.
Responsibilities and qualifications include definition of standard operating procedures, training and education to internal teams, creation of design history file deliverables, review and audit of design history files. Software Quality Compliance Engineer, Medical Devices Responsibilities Establish processes and deliverables for software as a medical device product development programs per the FDA and ISO design controls requirements and guidance documents. Collaborate with engineering and other product development teams in establishing standard operating procedures for the definition of design history file (DHF) and other design control deliverables.
Lead the creation of software risk management deliverables utilizing an ISO 14971 framework plus device master record and design history file elements to meet FDA and ISO requirements. Guide medical device development teams in their execution strategy to Design and Risk SOPs, review, approve, and audit DHF elements (e.g., plans, requirements, specifications, test protocols, test results, design traceability, risk management documents, design reviews, reports). Train and coach cross-functional peers on maintaining compliance to internal and external medical device quality system requirements and regulations.
Perform assessment and documentation of cybersecurity and data privacy practices in accordance with medical device state of the art requirements. Minimum Qualifications Bachelor's Degree in Software, Biomedical, or Electrical Engineering or other Technical Science 8+ years of experience in a highly regulated industry (e.g, Medical Devices, Bioengineering, Pharma, LifeSciences, Quality and/or Development Experience in the application of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1, MDD & EU MDR to SW Medical Devices Experience authoring technical reports, design history deliverables, business correspondence and standard operating procedures Proven communication skills. Experience presenting clearly to technical and non-technical audience with varying degrees of medical device knowledge.
Preferred Qualifications Knowledge of medical device cybersecurity and data privacy process requirements Working knowledge of Medical Devices with embedded firmware and systems with mobile and cloud applications Experience using software development tool chains and their integration into QMS deliverables or tool sets. Experience with Software as a Medical Device and Computer System Assurance best practices. ASQ CQE or similar certification Locations About Meta Meta builds technologies that help people connect, find communities, and grow businesses.
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$170,000/year to $240,000/year + bonus + equity + benefits Individual pay is determined by skills, qualifications, experience, and location. Compensation details listed in this posting reflect the base salary only, and do not include bonus, equity or sales incentives, if applicable. In addition to base salary, Meta offers benefits.
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