Senior Engineer, Post Market

The primary function of this position is to manage projects focused on design modifications of devices post release to market, for the purpose of maintaining device quality and compliance, securing regulatory approval, as well as reducing costs and increasing yields.

Reporting to: Manager, Post Market Engineering / Team Lead, Post Market Engineering

Find out more about Cook Medical here

• Collaborate with other Post Market / Manufacturing Engineering Teams to ensure the effective completion of all activities associated with Post Market Engineering projects / objectives.
• Ensure effective reporting to the Manager, Post Market Engineering Manager.
• Work closely to build effective relationships with other functions in particular Production, Quality and Regulatory teams.
• Provide mentorship to team members to ensure their development and the effective completion of project milestones.
• Responsibility for approval of design history file documentation.
• Lead the delivery of CAPA or Design projects with responsibility for the following:
• The completion of the Investigation / Root Cause Analysis ensuring consistency in terms of methodology used and outcome achieved.
• The identification and implementation of appropriate corrective / preventative action, and collaboration with other functions to ensure same if they are impacted.
• The verification of effectiveness of CAPA’s.
• Ensuring that CAPA’s are completed on time, planned effectively and that plans are tracked and communicated effectively to relevant stakeholders.
• 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.
• Identify and guide team in the successful implementation of:
• Design changes that will improve existing device quality, performance and efficacy.
• Cost reduction and yield/efficiency improvement opportunities.
• Support Regulatory Affairs as required with engineering input for design related submissions and renewals post initial release of devices to market.
• Maintenance and remediation of Design History Files for existing devices to ensure compliance with relevant procedures, standards or guidance documents.
• Maintenance of the Risk management files for existing devices (i.e. dFMEA, Risk Benefit Analysis).
• Support the post market surveillance of devices in terms of complaint investigation and risk analysis.
• Provide engineering support for post market clinical studies if required.
• Liaise with Research and Development teams to ensure the effective transfer of design history files for new devices from Research and Development to Post Market Engineering.
• 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.
• Benchmark systems and processes against best industry practice and modify and develop accordingly to further improve operations efficiencies.
• Responsible for operating general internal quality systems and documentation.
• Act as a Delegate for the Manager or Team Lead for document review as per Quality System Procedures.

• Bachelor’s degree is desired, preferably in engineering or a related field and / or relevant experience.
• Minimum of 5 years’ relevant experience is required.
• Strong interpersonal skills and the ability to communicate at all levels of the organisation.
• Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
• Proven problem-solving skills.
• Good computer skills including knowledge of Microsoft® Office.
• Excellent organisational and team building skills.
• High self-motivation.
• Willingness and availability to travel on company business.

About Cook Limerick  

Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook’s products for global markets.   

Our employee benefits include:   

• Hybrid Work Model    

• Company sponsored Defined Contribution pension scheme   

• Medical Health Insurance cover for you and your immediate family   

• Life Assurance and Income Protection cover   

• Educational Assistance    

• Performance related Bonus   

• Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks   

• Fully equipped gym on site   

• 39-hour week with flexible start & finish times    

• Paid time off to participate in volunteer activities   

• Free parking   

• Subsidised restaurant   

• Sports & Social club 

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