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.
Position: Engineer 2, Post Market
Reporting to: Team Lead, Post Market, Post Market Engineering
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. 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.
Other General Responsibilities
∙ Ensure that all activities are in compliance with:
* Cook's Code of Conduct.
* Cook's Quality System requirements.
* Company HR policies.
Qualifications
∙ Liaise with other Cook manufacturing facilities as required
∙ Bachelor's degree is desired, preferably in engineering or a related field and / or
relevant experience.
Required
∙ 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.