NPI Engineer

JWR Employment Specialists are recruiting an NPI Engineer for a Medical Device manufacturing company located in Boyle.

The NPI Engineer will be responsible for managing projects and the identification specification introduction management and validation of new equipment processes products and technologies. They will provide technical input and leadership on problem solving resolution of technical processing issues and implement process improvements.

The role will offer an attractive salary and benefits.

Duties include;

Manage develop and validate new process including running trials/feasibility studies for new product /product iterations and new technology to demonstrate capability and achieve key project deliverables (Cpk cycle times leadtime GM% etc.)

Designs and implements new methodologies materials machines processes or products to bring concept to market including essential product and process documentation

Uses a sciencebased approach to develop processes process improvements and technology improvements

Understand current processes taking a handson approach to understanding how these can be applied to new opportunities

Work with equipment and material vendors to mutually understand their and our technical process challenges to improve capability and eliminate cost

Prepare project plans that specify project phases tasks task interdependencies durations resource assignments and costs

Write and review new customer development proposals for development projects

Identify develop and implement plans for continuous improvement activities

Lead improvement initiatives as assigned including investigations trouble shooting driving effective determination of root cause and championing a structured approach to problem solving using lean tools and 6 sigma principals

Project manage and lead cross functional teams with responsibility for the introduction and validation of new processes/ new technology

Complete validation plans FMEAs validation protocols validation reports control plans and test method validations supported with appropriate statistical tools in accordance with quality system and the requirements of ISO13485 The Medical Device Regulation and FDA Quality System Regulations

Assess customer s validation needs and propose innovative solutions

Support teams to identify and specify new technology/tooling/materials required

Requirements

Skills and Qualifications:

Degree in a relevant engineering science or an equivalent discipline

3 year s work experience in industry Medical device or manufacturing experience is essential

Have the ability to effectively manage a simultaneous range of diverse activities

A Practical levelheaded individual with strong technical ability

Ability to work handson with a solid engineering background engaging crossfunctional groups equipment and material vendors to resolve technical issues

Excellent project management skills setting realistic objectives and delivering

Energetic and driven selfstarter with good communication and influencing skills and the ability to effectively simultaneously manage a wide range of diverse activities