Production Engineer / NPI Engineer

Orion Electrotech Ltd
16 May 2018
15 Jun 2018
Contract Type
Full Time
We a leading medical device company specialising in the design, development and manufacture of innovative products and services. Due to continued growth we have an exciting opportunity for a Production Engineer / NPI Engineer to join our highly motivated team.

The Production Engineer / NPI Engineer will provide manufacturing engineering support to Engineering Design and R&D project team and coordinate transfer of new products into manufacturing considering manufacturability and efficiency of processes.

Key responsibilities include - Production Engineer / NPI Engineer;

*Identifying production problems / deficiencies and be able to use a methodical system to solve these.

*Knowledge of documentation control procedures and engineering change management.

*Create and maintain controlled documentation such as; Process Flows, Process and Tool drawings, Process Routers, Bills of Materials, Work and Inspection Instructions.

*Write and execute Process Validation Protocol documentation for product, equipment and processes, this will include Process Failure Mode and Effects Analysis (PFMEA), process validation (Installation Qualification - IQ, Operational Qualification - OQ, Performance Qualification - PQ) plans and protocols.

*Optimising the manufacturing processes - improving efficiencies, reducing wastage, enhancing yield and reducing cost

Desired Skills & Experience - Production Engineer / NPI Engineer;

*Experience of production engineering within highly regulated industries such as medical or aerospace sectors.

*Experience in a manual cell manufacturing environment where lean initiatives have been practiced.

*Experience with automating and semi-automating manufacturing processes for medical products is a plus.

*Prior work experience with drug-device or biologic-device combination products is a plus.

*Experience establishing and validating pilot production lines

*Excellent writing skills for detailing specifications, processes, and creating manufacturing documentation, such as protocols, control plans, work instructions, and test methods.

*Experience in performing FMEA's, verifications and validations for medical devices products and processes.

*This is a hands-on position and you must have the ability to work effectively with small teams of 2 to 20 people

Orion Electrotech Ltd acts as both an Employment Business and Employment Agency and complies with the Conduct of Employment Agencies and Employment Businesses Regulations Act 2003.

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