Engineer 2, Post Market
Overview:
The primary function of this position is to lead and/or participate in projects focused ondesign 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 MarketReporting 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 theeffective 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 withresponsibility for the following:
o The completion of the Investigation / Root Cause Analysis ensuringconsistency in terms of methodology used and outcome achieved.
o The identification and implementation of appropriate corrective / preventativeaction, 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 thatplans 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 complaintinvestigation and risk analysis.
o 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 / orrelevant 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 andGMP 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.