Engineer 2, Post Market

4 months ago


Limerick, Ireland Cook Medical Full time

Overview

The primary function of this position is to lead and/or participate in projects focused on design modifications of devices post release to market, for the purpose of maintaining device quality and compliance, as well as reducing costs and increasing yields.

Reporting to: Team Lead, Post Market Engineering

Responsibilities

Lead or participate in CAPA or Design engineering projects. Collaborate with other Post Market / Manufacturing Engineering Teams to ensure the effective 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 particular Production, Quality and Regulatory Affairs teams. Support / lead the delivery of CAPA or Design projects / deliverables 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.Support projects focused on 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 resubmissions 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 (. 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. 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 required.

Qualifications

Bachelor’s degree is desired, preferably in engineering or a related field and / or relevant 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 and GMP 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.
  • Regulatory Specialist

    4 months ago


    Limerick, Ireland Pale Blue Dot® Recruitment Full time

    Our Client a leading Medical Device Company in Limerick is hiring a Regulatory Specialist.Responsibilities include but are not limited to the following:Coordination and planning of Post Market Surveillance (PMS) activities and reporting, including Post Market Performance Follow up (PMPF).Liaise with other departments on the relevant requirements for PMS and...

  • Chemist 2

    3 months ago


    Limerick, Ireland Cook Medical Full time

    Overview The primary function of this position is to lead and/or participate in projects focused on developing strategy with respect to chemistry, manufacturing, and controls (CMC) of combination drug devices , specifically providing oversight in method development and validation, compendial method verification and transfer , specification/acceptance...


  • Limerick, Ireland Cook Medical Full time

    Overview The Manufacturing Engineer 2, New Product Introduction will be responsible for key activities within New Product Introduction. Key activities will include leading projects to either introduce new products or support and improve existing products. More specific details are listed below. Reporting to: Manager, Manufacturing Engineering...


  • Limerick, Ireland Cook Medical Full time

    Overview The Regulatory Affairs Specialist 2 ensures regulatory compliance to the EU MDR at the office of the EU Authorised representative (AR). The EU AR Office is responsible for verifying compliance to the EU MDR on behalf of Cook Medical’s non-EU manufacturers. The Regulatory Affairs Specialist 2 serves as a communication liaison between the...


  • Limerick, Ireland Zenovo Limited Full time

    Position: Embedded Software Engineer ( 2 years+ experience) Location: Limerick ( required onsite 3-4 days per week) Zenovo Ireland are supporting a technology company with offices in Limerick, we are looking to recruit a permanent Embedded Software Engineer with 2+ years commercial experience. Our partner produce innovative products used in the retail, O&G,...


  • Limerick, Ireland Cook Medical Full time

    Overview The Regulatory Affairs Specialist 2 helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates,...


  • Limerick, Ireland Cook Medical Full time

    Overview The Manufacturing Engineer 2 (Test Method Validation) Reporting to: Manager, Manufacturing Engineering Responsibilities Develop and execute Test Method Validations for Test Equipment per current QMS/Regulatory standards. Validate and implement medical device manufacturing processes as assigned. Identify equipment/fixture installation qualification...


  • Limerick, Ireland Cook Medical Full time

    Overview The primary function of this role is to provide leadership and direction to the Post Market and Manufacturing Engineering teams, while taking overall responsibility for effective and efficient running of the department. The Director, Engineering is also responsible for working with Local and Global Functional Leaders, and Divisions to manage all...


  • Limerick, Ireland Cook Medical Full time

    Overview The Manufacturing Engineer 2 (Test Method Validation) performs and documents validations of medical device manufacturing processes. Reporting to: Manager, Manufacturing Engineering Responsibilities Develop and execute Test Method Validations for Test Equipment per current QMS/Regulatory standards. Validate and implement medical device manufacturing...


  • Limerick, Ireland Cook Medical Full time

    Overview The primary purpose of this position is to provide technical support to Production, Manufacturing Engineering and Research & Development. In addition, drive process improvements to increase Manufacturing efficiency plus further develop manufacturing activities within the plant. Reporting to: Manager, Manufacturing Engineering ...

  • Head of Go-to-Market

    6 months ago


    Limerick, Ireland Prosperity Full time

    Our client is a native Irish company, based in Limerick, that offers an App to simplify and modernize clinical trials (clinical software). They are currently seeking a Head of Go-to-Market to lead the team responsible for building and activating sales lead generation strategies. The role is essential for driving growth through the establishment of...


  • Limerick, Ireland Cook Medical Full time

    Overview The primary function of this role is to provide Quality Engineering support to Production, Quality Control, Purchasing, Facilities, IT, Regulatory, Analytical Lab, Research and Development and Engineering Sustaining teams This includes, but is not limited to, providing support to process validation, change requests, non-conforming product issues,...


  • Limerick, Ireland Analog Devices Full time

    The Advanced Data Converter Platform Group (ADG) Team develops next-generation high-speed converter, transceiver, and digital signal processing platforms in deep-submicron processes for the most demanding mixed-signal applications. These big SoC (System-On-Chip) developments span a range of high-performance, RF mixed-signal applications and serve the...


  • Limerick, Ireland Cook Medical Full time

    Overview Work as part of the Quality Engineering to provide an efficient service to our customers internally and externally in dealing with product complaints issues and other relevant quality assurance projects as they arise. Reporting to: Team Lead, Quality Engineering Department: Complaints Responsibilities Department:...


  • Limerick, Ireland Prosperity Full time

    Our client is a native Irish company, based in Limerick, that offers an App to simplify and modernize clinical trials (clinical software). They are currently seeking a motivated Senior Marketing Ops specialist to help them manage their marketing automation infrastructure and scale the execution of the operations. You’ll take part of the continued growth...


  • Limerick, Ireland Analog Devices Full time

    The Advanced Data Converter Platform Group (ADG) Team develops next-generation high-speed converter, transceiver, and digital signal processing platforms in deep-submicron processes for the most demanding mixed-signal applications. These big SoC (System-On-Chip) developments span a range of high-performance, RF mixed-signal applications and serve the...


  • Limerick, Ireland O'Loughlin Project Engineers Limited Full time

    Senior Site Project EngineerFull-Time Position, based onsite in Limerick Main Duties & Responsibilities:Interact with and support the engineering department in the delivery of various capital projects.Management of major work packages, covering some or all project phases (from procurement, through to build and post-installation support) for successful...


  • Limerick, Ireland O'Loughlin Project Engineers Limited Full time

    Senior Site Project EngineerFull-Time Position, based onsite in Limerick Main Duties & Responsibilities:Interact with and support the engineering department in the delivery of various capital projects.Management of major work packages, covering some or all project phases (from procurement, through to build and post-installation support) for successful...

  • RF Engineer

    1 month ago


    Limerick, Ireland Reperio Human Capital Full time

    I am looking for talented RF engineers who are keen to join a well-established company focusing on the production and development of Health and safety Products. Within the company there has been a large investment into the RF department with a very modern lab with incredibly up to date equipment. The successful person will be someone who has a genuine...


  • Limerick, Ireland Wurth Ireland Full time

    Join our Wurth Community!The Wurth Group is a leading provider of industrial consumable products, with over 400 companies and a global workforce of 83,000 people. Our commitment to high-quality products, innovation and excellent customer service has earned us an enviable reputation and continued growth. Wurth Ireland has been active for over 40 years from...