Overview
The 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 Market Reporting to: Team Lead, Post Market, Post Market Engineering
Responsibilities
∙ 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 ensuring consistency in terms of methodology used and outcome achieved. o The identification and implementation of appropriate corrective / preventative action, and collaboration with other functions to ensure same if they are impacted. o The verification of effectiveness of CAPA’s. o Ensuring that CAPA’s are completed on time, planned effectively and that plans are tracked and communicated effectively to relevant stakeholders. o Where Engineering are not the CAPA assignee / process owner work closely with CAPA / Process owners to provide guidance on items above ensuring a consistent 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 design related submissions and resubmissions post initial release of devices to market. o Maintenance and remediation of Design History Files for existing devices to ensure compliance with relevant procedures, standards or guidance documents. 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 complaint investigation 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: o Cook’s Code of Conduct. o Cook’s Quality System requirements. o Company HR policies.∙ Liaise with other Cook manufacturing facilities as required.
Qualifications
∙ 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