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Risk Management Engineer

Company: HP Inc
Location: vancouver
Posted on: May 3, 2021

Job Description:

Technical leader in a new incubation group within HP. This technical contributor must understand and apply diagnostic assay product knowledge; identify technical risks and apply appropriate document methods for management in accordance with regulatory requirements. Successfully operates in the most complex disciplines, in which the company must operate to be successful. Leads large, cross-division functional teams or projects that affect the organizations long-term goals and objectives. Provides mentoring and guidance to lower level employees. Routinely exercises independent judgment in developing methods, techniques and criteria for achieving objectives. Develops strategy and sets functional policy and direction.

Responsibilities:

  • Contribute to the evolution of QMS in the area of SOPs for Risk Management and it's interactions with other processes
  • Lead in Healthcare Transformation as a Risk Coach and Trainer
  • Apply system and software product knowledge to risk management activities (e.g. Product specific Risk Plan, FMEA, Risk Report)
  • Perform periodic post-production risk assessment
  • Ensure product risk files are updated per defined schedules and to align with changes to external or internal risk guidance
  • Advise R&D personnel on risk management activities throughout the product lifecycle. This includes risk management plans and reports, hazard analysis, design and process risk assessment
  • Advise R&D personnel on risk management associated with Corrective & Preventive Actions (CAPA)
  • Drive continuous improvement efforts through facilitating, leading and collaborating with cross functional teams
  • Represent R&D during internal and external audits on matters related to risk management
  • Keep abreast of emerging regulatory/industry trends regarding risk management
  • Additionally support team projects as needed (e.g. Quality required documentation support)

Education and Experience Required:

  • Bachelor's or Master's degree in Mechanical, Electrical, Bioengineering or other Engineering, Computer Science, or equivalent.
  • Experience: A minimum of 7 years in the diagnostics industry, preferably in the diagnostic device development environment . A minimum of 3 years direct demonstrated experience with Risk Management.

Knowledge and Skills:

  • Excellent understanding and practical application of medical device quality system regulations.
  • Excellent verbal and written communication skills
  • Strong interpersonal skills and ability to lead teams
  • Excellent problem solving skills
  • Ability to understand and apply system and software product knowledge
  • Ability to recognize problems and take corrective measures
  • Experience with risk management processes and tools
  • Experience with in vitro medical devices
  • Ability to query and analyze technical, scientific and medical information
  • Ability to communicate results and propose recommendations to a technical audience of varying skill levels
  • Excellent project management skills
  • Ability to manage multiple ongoing tasks, be responsive to critical situations and changing priorities
  • Ability to work in a self-motivated and self-directed manner

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Keywords: HP Inc, Vancouver , Risk Management Engineer, Other , vancouver, Washington

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