OverviewThe primary function of this position is to lead and/or participate in projects focused ondesign modifications of devices post release to market, for the purpose of maintaining devicequality and compliance, as well as reducing costs and increasing yields.Position: Engineer 2, Post MarketReporting to: Team Lead, Post Market, Post Market EngineeringResponsibilities∙ Lead or participate in CAPA or Design engineering projects.∙ Collaborate with other Post Market / Manufacturing Engineering Teams to ensure theeffective completion of all activities associated with department projects / objectives.∙ Ensure effective reporting to the Team Lead, Post Market Engineering.∙ Work closely to build effective relationships with other functions in particularProduction, Quality and Regulatory Affairs teams.∙ Support / lead the delivery of CAPA or Design projects / deliverables withresponsibility for the following:o The completion of the Investigation / Root Cause Analysis ensuringconsistency in terms of methodology used and outcome achieved.o The identification and implementation of appropriate corrective / preventativeaction, and collaboration with other functions to ensure same if they areimpacted.o The verification of effectiveness of CAPA’s.o Ensuring that CAPA’s are completed on time, planned effectively and thatplans are tracked and communicated effectively to relevant stakeholders.o Where Engineering are not the CAPA assignee / process owner work closelywith CAPA / Process owners to provide guidance on items above ensuring aconsistent approach and outcome across all functions on site.o Support projects focused on the successful implementation of:▪ Design changes that will improve existing device quality, performanceand efficacy.▪ Cost reduction and yield/efficiency improvement opportunities.o Support Regulatory Affairs as required with engineering input for designrelated submissions and resubmissions post initial release of devices tomarket.o Maintenance and remediation of Design History Files for existing devices toensure compliance with relevant procedures, standards or guidancedocuments.o Maintenance of the Risk management files for existing devices (i.e. dFMEA,Risk Benefit Analysis).o Support the post market surveillance of devices in terms of complaintinvestigation and risk analysis.o Provide engineering support for post market clinical studies if required.Other General Responsibilities∙ Ensure that all activities are in compliance with:-Cook’s Code of Conduct.-Cook’s Quality System requirements.-Company HR policies.∙ Liaise with other Cook manufacturing facilities as requiredQualifications∙ Bachelor’s degree is desired, preferably in engineering or a related field and / orrelevant experience.∙ Minimum of 3 years’ relevant experience is required.∙ Strong project management skills (proven track record of same desirable).∙ Strong interpersonal skills and the ability to communicate across functions.∙ Strong knowledge of medical device quality standards ISO13485/FDA practices andGMP or similar regulated industry standards.∙ Proven problem-solving skills.∙ Good computer skills including knowledge of Microsoft® Office.∙ Strong organisational, collaboration, and team building skills.∙ High self-motivation.∙ Willingness and availability to travel on company business.
