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:
o The completion of the Investigation / Root Cause Analysis ensuring
consistency in terms of methodology used and outcome achieved.
o The identification and implementation of appropriate corrective / preventative
action, and collaboration with other functions to ensure same if they are
impacted.
o The verification of effectiveness of CAPA’s.
o Ensuring that CAPA’s are completed on time, planned effectively and that
plans are tracked and communicated effectively to relevant stakeholders.
o 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.
o 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.
o Support Regulatory Affairs as required with engineering input for design
related submissions and resubmissions post initial release of devices to
market.
o Maintenance and remediation of Design History Files for existing devices to
ensure compliance with relevant procedures, standards or guidance
documents.
o Maintenance of the Risk management files for existing devices (i.e. dFMEA,
Risk Benefit Analysis).
o Support the post market surveillance of devices in terms of complaint
investigation and risk analysis.
o Provide engineering support for post market clinical studies if required.
