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General Electric Risk Manager - Cyber in Waukesha, Wisconsin

Role Summary:The Risk Manager-Cyber assesses cyber-security risk associated with the use of medical devices designed and/or manufactured by GEHC. Risk Management is an integral part of the product development process over the commercial life of the product & includes identifying hazards, estimating, evaluating & controlling risk & monitoring the effectiveness of the control of risk. The Risk Manager-Cyber implements, improves, & directs risk management programs, processes & procedures across product lines.

Essential Responsibilities:

  • Develop processes to effectively identify and assess safety risks associated with cyber-security vulnerabilities in medical devices.

  • Work closely with the GEHC cyber-security team to establish coordination between the two organizations to ensure timely and effective identification and resolution of vulnerabilities; participate in established vulnerability triage process to ensure continued connection between quality and cyber-security.

  • Develop and implement systematic approach to identify standardized risk association between digital and physical components.

  • Assist in improving complaint handling system to ensure capture of cyber-security related entries.

  • Work with cross-functional cyber-security and product teams to identify potential structural product improvements to reduce potential future risks.

  • Develop management reports to qualify and monitor risks to ensure risk responses are timely and effective

  • Determine the most effective methods for handling risk exposures and recommend mitigation to senior management

  • Decompose hazards into lower level hazards and hazardous situations

  • Total product lifecycle monitoring - linking product development risk management to post-market risk assessments

  • Identify and drive improvements to overall Risk Management processes and documentation to provide clear flow down of regulations

  • Educate, train, advise and coach business leaders and QA/RA practitioners on the related regulations, procedures and work instructions

  • Work closely with the Clinical/Medical professionals to assure their input is foundational to the hazards and harm inputs to risk management

  • Assure probability of occurrence is consistently applied during failure investigation and risk Analysis

Qualifications/Requirements:

  • Bachelor Degree in scientific / clinical discipline or engineering, and a minimum of 5 years of progressively more responsible Quality Assurance or Regulatory Affairs experience in the medical device, pharmaceutical, chemical or banking/financial security industry; OR high school diploma/GED and a minimum of 12 years of progressively more responsible Quality Assurance or Regulatory Affairs experience in the medical device, pharmaceutical, chemical or banking/financial security industry

  • A minimum of 3 years of Risk Management experience in the medical device, pharmaceutical, chemical industry including experience facilitating risk working sessions

  • Experience with Risk Management standards (ISO 14971 for medical devices and ICH Q9 for pharmaceuticals)

  • Strong technical background in system architecture, specifically related to interaction between digital and components in relevant field.

  • Knowledge of risk management methods and practice, cost/benefits analysis, and risk models and project management practices

  • Experience with risk management tools such as FMEA, FTA, HAZOP, fish-bone diagrams, and robust design techniques

  • Strong analytical skills

  • Demonstrated knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, P&PC, Complaints, Document Control, etc)

  • Demonstrated experience with ISO, GxP, FDA or other key regulatory bodies

  • Ability to communicate effectively in English

  • Prior experience using word processing, spreadsheet, and presentation software

Desired Characteristics:

  • Working knowledge of ISO 14971 - Medical Device Risk Management Standards, and ICH Q9 Pharma Risk Management Standard

  • Demonstrated experience leading and facilitating change

  • Demonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions including but not limited to engineering, operations, regulatory affairs, and medical affairs

  • Knowledge of product family and P&L organization

  • ASQ Certification as Quality Engineer (CQE), Quality Manager (CQM), Operations Excellence (OE), or other related discipline

  • Demonstrated compliance program management/leadership experience. Able to prioritize, plan, delegate and evaluate deliverables to established strategic goals

  • Demonstrated process/lean skill to drive project execution with discipline

  • emonstrated collaboration, negotiation & conflict resolution skills. Ability to build a connection with the team through personal involvement & trust & providing feedback & coaching to help develop others

  • Visibly demonstrates comfort & efficacy in presenting to and in communicating with top organizational leadership & internal & external customers, responding in a professional manner

  • Familiar with classic quality tools & experienced in applying them to monitor function performance

  • Global regulatory experience & demonstrated experience interfacing with FDA

  • Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures)

  • CISSP Preferred

About Us:GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.com

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.

Additional Eligibility Qualifications:GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).Additional Locations:United States;Wisconsin;Waukesha;

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