Meta AR/VR Job | Quality Systems Lead Engineer, Hardware Medical Devices
Citys（岗位城市）: Sunnyvale, CA
Reality Labs seeks an experienced medical device design control professional to be the Quality Systems Lead Engineer for Hardware Devices in the establishment of design controls, production controls, and risk management processes and files (DHF, RMF, DMR) in support of the quality management system (QMS)organization. This subject matter expert will work cross functionally throughout the organization to champion the adoption of processes. The ideal candidate will act as an internal consultant and have deep domain experience in electromechanical devices using the principles and requirements from 21 CFR 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601-1, etc. Responsibilities and qualifications include definition of standard operating procedures, training and education to internal teams, generation of design and risk file deliverables, review and audit of design history files, audit and qualification of suppliers, and design transfer to manufacturing.
Bachelor’s Degree in Biomedical, Mechanical or Electrical Engineering or other Technical Science
6+ years of work 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 and other US regulations, IEC 62304, IEC 60601-1, MDD & EU MDR
Experience authoring technical reports, business correspondence and standard operating procedures
Proven communication skills. Experience presenting clearly to technical and non-technical audience
Establish processes and deliverables for hardware medical device product development programs per the FDA and ISO design controls and supplier qualification for electromechanical products.
Collaborate with systems and software engineering and other product development teams in establishing standard operating procedures for the definition of design history file and other related deliverables.
Lead the creation of product risk management deliverables utilizing an ISO 14971 framework.
Guide medical device development teams in their execution strategy to Design Control, Risk Management, and other related SOPs.
Review, approve, and audit DHF elements (e.g., plans, requirements, specifications, test protocols, test results, design traceability, risk management documents, reports, design reviews).
Perform internal audits and possible contract manufacturer audits to verify compliance with QMS requirements for design, development, and manufacturing of medical devices.
ASQ CQE or similar certification
Working knowledge of electromechanical medical devices with embedded firmware and systems with mobile and cloud applications
Experience using software tools for document controls, risk management, and design traceability through the whole product lifecycle
Working with contract manufacturers and supply chains in Asia Pacific region