The primary purpose of this position is to focus on the development of processes required to

manufacture device designs which are developed by R&D in Cook Medical.

Position:

Associate Process Development Engineer

Reporting to:

Senior Process Development Engineer

Responsibilities:

Collaborate in a team of engineers focused on identification, development, and

implementation of new processes (within Cook or with third parties) required for the
manufacture of device designs which are developed by R&D in Cook Medical.
Completion of process validation for new processes associated with NPIs and or
process development.
Ensure that a risk based approach is applied during the development implementation
and validation of all processes both within Cook and with third party suppliers.
Where appropriate apply Lean Manufacturing principles to the design and
implementation of new processes.
Completion of process documentation (PFMEAs, Production Instructions, Drawings
etc.) associated with NPIs and or process development.
Collaborate with other R&D Teams to ensure the effective completion of all activities
associated with an R&D Engineering project / objective.
Work closely to build effective relationships with other functions in particular
Operations, Quality and Regulatory teams.
Supplier selection, process development and validation.
Support Regulatory Affairs as required with engineering input for process related
submissions and renewals prior to and post initial release of devices to market.
Ensuring the effective transfer of products from other Cook entities.
Provide engineering input and support to those responsible for Supplier 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
new processes and production lines.
Provide engineering input and support for the investigation and resolution of Non
Conformances associated with devices post release to market.
Support the post market surveillance of devices in terms of complaint investigation
and risk analysis.

Other General Responsibilities:

Rev 0, Last Reviewed: 2nd March, 2016

Uphold the Cook Medical compliance culture and ensure that compliance
requirements are always met.
Liaise with other Cook manufacturing facilities.

Support other cross functional groups to achieve company goals.

Benchmark systems and processes against best industry practice and modify and
develop accordingly to further improve operations efficiencies.
Ensure that Cooks Code of Conduct is considered in all business matters carried out on
Cooks behalf.

Qualifications:

Formal production/engineering qualification and/or relevant experience in the area of

NPI and or process development.
Strong interpersonal skills and the ability to communicate at all levels of the
organisation.
Basic 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.

High self-motivation.

Willingness and availability to travel on company business.

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Rev 0, Last Reviewed: 2nd March, 2016

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Manager/Supervisor Print Name

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Manager/Supervisor Signature

Rev 0, Last Reviewed: 2nd March, 2016

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