Job Opportunities in Ireland


September 11, 2024

Cook Group

Limerick

FULL TIME


Engineer 2, Post Market

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

Find out more about Cook Medical here
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 (i.e. d FMEA, 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.

Latest Job Opportunities


September 18, 2024

State Street Corporation
Middle Office - Associate

Drogheda

FULL TIME & OTHER

View Details

September 17, 2024

Brown Thomas Arnotts
Forever New, Sales Consultant, Part Time

Limerick

PART TIME & OTHER

View Details

September 17, 2024

BoyleSports
Retail Team Member - Longoford

Longford

FULL TIME & PART TIME

View Details

September 17, 2024

Northern Trust Corp.
Cyber Security Threat Management Analyst

Limerick

FULL TIME

View Details

September 17, 2024

Shiseido
NARS Makeup Artist - Brown Thomas, Limerick (30 Hours)

Limerick

OTHER

View Details

Similar Jobs


September 10, 2024

BAXTER
Project Engineer

Castlebar

FULL TIME

View Details

August 22, 2024

Unum
Infrastructure Engineer

Carlow

FULL TIME

View Details

September 10, 2024

GEA Refrigeration Ireland Ltd
Apprentice Refrigeration Engineer

FULL TIME

View Details

September 10, 2024

Cook Group
Quality Engineer 1, Complaints

Limerick

View Details

September 10, 2024

Cook Group
Quality Engineer 2

Limerick

View Details

September 4, 2024

Tech Domain
IT & Network Support Engineer

Carlow

PART TIME

View Details

New Jobs from This Company


September 12, 2024

Cook Group
Engineer 1, Post Market

Limerick

FULL TIME

View Details

September 12, 2024

Cook Group
Regulatory Affairs Specialist (Hybrid Role)

Limerick

FULL TIME

View Details

September 11, 2024

Cook Group
Research and Development Engineer 2

Limerick

FULL TIME

View Details

September 10, 2024

Cook Group
Quality Engineer 1, Complaints

Limerick

View Details

September 10, 2024

Cook Group
Quality Engineer 2

Limerick

View Details