Risk Management Engineer

Descripción y detalle de las actividades

This position has responsibility and authority for : 45% involvement in documenting product escalation based on quality-related events, 45% Risk Management document support, 10% quality advocacy and project management. Escalation Process : Support documentation (TrackWise, Agile, Neptune, other systems as they arise) for escalation decisions arising from PostMarket review, Manufacturing, Process, or other sources.Interact with and guide requestors through the process, asking the proper questions to expedite the decisions and documentation.Participate in trending reviews for EscalationsRisk ManagementParticipate in Risk Analyses for new and existing products, including review of both hardware and software.Using data from Post Market reviews, update risk documentation as needed, following confirmations with Project QEs and Design Engineering.Work with Design Engineering to maintain tracing of risk to requirement to test.Participate in review of technical and quality information for regulatory submissions.Quality Process ImprovementsAs needed, participate in Quality process improvement projects (CAPA, Process NonConformance, Quality Plans, other process improvements)

Experiencia y requisitos

Skill / Job Requirements : Competency Requirements : In order to adequately perform the responsibilities of this position the individual must possess : English Level : High (Good writing and speaking skills in English)Education : Bachelor degree in electrical, mechanical or system engineering, life sciences, mathematics, or physics. Advanced degree is a bonus.Able to navigate quality and compliance system with minimal oversight on individual projects.Basic knowledge of CFR 21 820 / ISO 13485 requirements for making process or design changes.Understands product risks, able to work with design and quality engineers to update risk documents.Understands Design Controls, Change Controls, Product, and Engineering Processes.Uses data to quantitatively communicate problem or issue.Basic functionality in PowerPointUnderstands typical Excel data analysis operations (bonus for Vlookup, Pivot table and pivot chart functions).Works with Peers to understand and document issues.Operates with minimal oversight for basic problems or assignments, and escalates appropriately for issues requiring clarification.Preferred : 1 to 3years of working experience in a medical device companyExperience with Agile / ACCS, TrackWise, or other electronic documentation systems (desired)Participation in internal / external audits conductedAware of SPC & Six Sigma methodology and tools (e.g. uses DMAIC process and basic tools such as 5 Why's, control charts, fishbone diagram).Personality Requirements Able to cope with changes and uncertainties; and handle associated risks comfortably.Ask questions and don’t stop at the first answer. Analyze deeply to ensure the solution is the most effective solution.Brings unpleasant facts to discussion, does not hold back information.Driven by results. Fully supports team decision, even if he / she disagrees with the decision.