Summary:

　　Reality Labs seeks an experienced medical device design control professional to be the Hardware Compliance Lead Engineer for Medical Device 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.

　　Required Skills:

　　Hardware Quality Compliance Lead Engineer, Medical Devices Responsibilities:

　　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.

　　Minimum Qualifications:

　　Minimum Qualifications:

　　Bachelor’s Degree in Biomedical, Mechanical or Electrical Engineering or other Technical Science

　　8+ 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

　　Experience presenting clearly to technical and non-technical audience

　　Preferred Qualifications:

　　Preferred Qualifications:

　　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

　　Experience with eyewear or smart glasses

　　Public Compensation:

　　$170,000/year to $240,000/year + bonus + equity + benefits

　　Industry: Internet

　　Equal Opportunity:

　　Meta is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law. Meta participates in the E-Verify program in certain locations, as required by law. Please note that Meta may leverage artificial intelligence and machine learning technologies in connection with applications for employment.

　　Meta is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know at [email protected].