Principal Responsibilities

1. Project Management:

 Update and implement design history files for product design, usage and
performance.
 Manage project within set schedule, and ensure that projects entrusted are
completed within set timelines
 Execute the product transfer to production for projects entrusted.
 Follow-up with suppliers regarding purchasing of components, tooling, equipment and
services in relation to project work.
 Perform design review meetings for the projects assigned.
 Have a good understanding of R&D project requirements (studies CCRF, AP, CAR)
 Responsible for project planning & follow-up, from kick-off to implementation
 Determine the need for resources (manpower, machine, cost) in relation to project
assigned
 Work closely with other departments for improvements and project implementations.
 Assist R&D engineers to provide guidance on respective projects.

1. Technical studies:

 Design, develop and/or improve different processes & tooling.
 Perform engineering tests, measurement and analysis as an effort to improve product
or processes.
 Design and develop new test methods as needed.
 Perform yearly review of R&D documents as required.
 Work on Natec ERP system (X3) in relation to projects assigned.
 Perform benchmarking of competitors products.
 Development of new products.

1. Technical Report:

 Define and write protocols for product validation.
 Write project report on OQ (Operational Qualification), PQ (Process Qualification),
PPQ (Product Performance Qualification) & MVP (Master Validation Protocol)
 Work with CAD (autocad/solidworks) drawings in relation to project entrusted.
 Write technical report and PowerPoint presentations as required.
 Complete project documentation for Design History Files of project as required.
Perform Risk analysis and FMEA in relation to product design, manufacture and
usage.
 Assist regulatory affairs in answering questions linked to regulatory submission.

Education / Experience Requirements
 Graduate of a major engineering school.
 Bachelor degree in Mechanical engineering.
 7 to 10 years’ experiences in medical device manufacturing company and in research and
development.
 Experience in R&D and product/process improvement will be an advantage.
Specialized Skills / Other Requirements
 Good knowledge on Autocad & Solidworks
 Good knowledge on minitab
 Good knowledge on statistics analysis
 Good knowledge on pack office
 Ability to work with rigour
 Ability to manage a simple project and deliver it on time
 Good accountability
 Good communication skills in both english & french, in both written and verbal.
Benefits:

• Training plans
• Medical Insurance
• Team Building
• Transport