Risk Management Engineer

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 processesLead in Healthcare Transformation as a Risk Coach and TrainerApply system and software product knowledge to risk management activities (e.g. Product specific Risk Plan, FMEA, Risk Report)Perform periodic post-production risk assessmentEnsure product risk files are updated per defined schedules and to align with changes to external or internal risk guidanceAdvise R personnel on risk management activities throughout the product lifecycle. This includes risk management plans and reports, hazard analysis, design and process risk assessmentAdvise R personnel on risk management associated with Corrective & Preventive Actions (CAPA)Drive continuous improvement efforts through facilitating, leading and collaborating with cross functional teamsRepresent R during internal and external audits on matters related to risk managementKeep abreast of emerging regulatory/industry trends regarding risk managementAdditionally 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 skillsStrong interpersonal skills and ability to lead teamsExcellent problem solving skillsAbility to understand and apply system and software product knowledgeAbility to recognize problems and take corrective measuresExperience with risk management processes and toolsExperience with in vitro medical devicesAbility to query and analyze technical, scientific and medical informationAbility to communicate results and propose recommendations to a technical audience of varying skill levelsExcellent project management skillsAbility to manage multiple ongoing tasks, be responsive to critical situations and changing prioritiesAbility to work in a self-motivated and self-directed manner#LI-post

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