Meta AR/VR Job | Design Controls Manager, Medical Devices | Oculus
Job（岗位）: Design Controls Manager, Medical Devices | Oculus
Type（岗位类型）: Design | Operations, Product Strategy
Citys（岗位城市）: Sunnyvale, CA | Redmond, WA
Date（发布日期）: 2022-3-25
Summary（岗位介绍）
Reality Labs is looking for an experienced medical devices design controls professional to lead the establishment of design control and risk management processes for the organization. This role is looking for a subject matter expert that can work cross functionality throughout the organization to champion the adoption of processes which are new to Reality Labs. The ideal candidate will act as an internal consultant and have deep domain experience in electromechanical devices or in software as a medical device development 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, review and audit of design history files, and design transfer to manufacturing.
Qualifications（岗位要求）
Bachelor’s Degree in Biomedical, Mechanical or Electrical Engineering or other Technical Science
8+ years of work experience in a highly regulated industry (ex. Medical Devices, Bioengineering, Pharma, LifeSciences, Quality and/or Development etc.)
Demonstrated knowledge and experience in the application of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1, MDD & EU MDR
Knowledge to author technical reports, business correspondence and standard operating procedures
Proven communication skills. Experience presenting clearly to technical and non-technical audience
Description（岗位职责）
Establish processes and deliverables for medical device product development programs per the FDA and ISO design controls and supplier qualification for electromechanical products
Collaborate with systems engineering and product development teams in establishing standard operating procedures for the definition of design history file 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 and Risk SOPs, review, approve, and audit DHF elements (e.g., plans, requirements, specifications, test protocols, test results, design traceability, risk management documents, reports)
Train and coach cross-functional peers on maintaining compliance to internal and external Medical Device Quality System requirements and regulations
Perform internal audits and possible contract manufacturer audits to verify compliance with QMS requirements for design, development, and manufacturing of medical devices
Additional Requirements（额外要求）
ASQ Certified Quality Engineer, Certified Quality Auditor, or similar certification
Working knowledge of electromechanical medical devices with embedded firmware, and systems with mobile and cloud applications (SaMD)
Experience implementing and using software tools for document controls, risk management, and design traceability through the whole product lifecycle
Experience establishing a new Quality Management System at a large, complex organization
