Engineer 2, Post Market
Full time
at Cook Medical Incorporated
in
Ireland
Posted on April 20, 2024
Job details
Overview
The primary function of this position is to lead and/or participate in projects focused on design and / or process 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 EngineeringResponsibilities
- Lead or participate in engineering projects in any one of the following Post Market Engineering areas (detailed below) as required - CAPA or Design.
- Collaborate with other Engineering Teams to ensure the effective completion of all activities associated with Post Market Engineering 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.
- CAPA
- Lead or participate in engineering projects focused on the support / completion of CAPAs (related to design, procedures and systems).
- The completion of the unvestigation / root cause cnalysis 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.
- Design
- Identify and undertake 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 (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.
- Work with CAPA team as required to Root Cause CAPA’s and implement changes associated with same.
- Identify and undertake projects focused on the successful implementation of:
- 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 in engineering or related field required and minimum of 3 years’ relevant experience
- 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.
- 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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