JOB TITLE: Project Engineer, NPI - Contract
DEPARTMENT : End to End Hip & Shoulder Delivery - NPI
REPORTS TO: Engineering Team Leader
THE PROJECT:
New Hip Implant system
THE ROLE:
On a daily basis your work in NPI will interact with Quality, Operations and the Design team to develop this system throughout its lifecycle from concepts to market launch. You will own either a process step in a project or a process technology for multiple projects within the End-to-End Hips Project Delivery Team. The project team will develop, qualify & launch an end-to-end manufacturing process capable of making implants to safety, quality, service and cost standards.
THE IDEAL CANDIDATE:
A motivated and organised individual with strong technical or process experience. A strong team player that will deliver new process steps and associated technologies within their area. You will need strong interpersonal skills, be able to collaborate effectively to resolve technical challenges.
PRINCIPAL ACCOUNTABILITIES:
1. Process development, Characterisation, Qualification & Validation
2. Planning of key deliverables into action plans with the help of the Project Manager
3. Regular reporting on the status, performance, and risks of your process / technology
4. Participate in DFM reviews with Design Team to minimize lifecycle cost.
5. Minimise Environmental and Health & Safety effects of your work.
6. Adhere to the company's procedures as detailed in the SOP manual.
7. Support Regulatory Affairs with product submissions.
8. KPI develop, track, and deliver.
9. All other duties as directed by direct manager.
ESSENTIAL CRITERIA:
1. Third level Engineering degree or similar discipline.
1. 3 plus years' experience in product / process development within a regulated environment.
2. Self-motivated, with focus on Quality, Delivery and Cost.
3. Proven Root Cause analysis and problem-solving techniques
DESIRABLE CRITERIA:
1. Exposure to Project Management
2. Knowledge of medical device quality & regulatory systems
3. Certified Six Sigma qualifications.