Senior Sustaining Design Engineer

On behalf of our client, a global medical devices company, we are currently recruiting for a Senior Sustaining Design Engineer. This is a new permanent, full-time role.

Overview:

The primary function of this position is to manage a team of Engineers focused on design and / or process 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.

Responsibilities:

• 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:

• Third level qualification in Quality, Science or Engineering
• Proven knowledge and experience (min 4 years) of working with ISO13485:2003, ISO14971: 2000, the Medical Device Directive and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry.
• Previous supervisory experience would be beneficial.
• Excellent communication and inter-personal skills.
• Good working knowledge of Microsoft Office.
• Proven Problem-Solving Skills.
• Good working knowledge of statistics.
• Knowledge and experience of all aspects of validation.

For a full Job Spec and to apply for this role please call Deirdre 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. Tel: +353 1 2784671