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Job Details

NEW Sustaining Engineer

Company: Thornshaw Recruitment
Location: Limerick
Reference: DB9175R
Closing Date: 09 Jan 17
Type: Permanent
Salary (£): On Application
Benefits:

Job Summary:

On behalf of our client, a global medical device company, we are recruiting for a Senior Sustaining Engineer.

Requirements:

Responsibilities of the role will include the following: 

Job Description: 
• Lead a team of engineers focused on any one of the following Sustaining Engineering areas (detailed below) as required - CAPA, Design or Manufacturing. 
• Provide leadership and mentoring to team members to ensure their development and the effective completion of the activities associated with their role. 
• Work with Sustaining Engineering Manager and other Snr. Engineers to ensure the appropriate allocation of resources and prioritisation of efforts for the overall Sustaining Engineering group. 
• Collaborate with other Sustaining Engineering Teams to ensure the effective completion of all activities associated with a Sustaining Engineering project / objective. 
• Ensure effective reporting to the Sustaining Engineering Manager. 
• Work closely to build effective relationships with other functions in particular Production, Quality and Regulatory teams. 
CAPA 
• Lead a team of engineers focused on the support / completion of CAPAs (related to design, procedures and systems, or manufacturing processes). 
• 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. 

Design 
• 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. 
• Work with CAPA team as required to Root Cause CAPA’s and implement changes associated with same. 

Manufacturing 
• Identify and guide the team in the successful implementation of: 
• Process changes that will improve existing device quality, performance and efficacy. 
• Cost reduction and yield/efficiency improvement opportunities. 
• Provide engineering input and support for the investigation and resolution of Non Conformances associated with devices post release to market. 
• Support Regulatory Affairs as required with engineering input for process related submissions and renewals post initial release of devices to market. 
• Provide engineering input and support to those responsible for Vendor instigated changes. 
• Liaise with R&D and Process Development teams to ensure the effective transfer of new devices from Development to Sustaining cycles. 
• Responsible for process engineering layout plans and implementation in relation to line extensions or redesign. 
• Support the post market surveillance of devices in terms of complaint investigation and risk analysis. 


Qualifications/Requirements: 
• Formal production/engineering qualification and relevant experience in at least one of the following areas: Manufacturing Engineering/Device Design & Development /CAPA. 
• Strong proven people management skills. Previous experience in a supervisory position desired. The ability to supervise, lead and motivate a group of talented engineering staff. 
• 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.


For more information and to apply for this role please call Stephanie on +353 1 2784671 or e-mail dbolger@thornshaw.com 

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671

Apply for this job: NEW Sustaining  Engineer

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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