Project Engineer - custom made devices

Project Engineer - custom made devices

Job Purpose:

My client is currently recruiting for a Project Engineer, Contribute on the EU Medical Device Regulation transition program across the Joint Reconstruction business in particular on Custom-made devices.

The candidate must be highly motivated with a strong Project Engineering background who has experience in working in the medical device industry. The successful candidate will be working within the Custom-made devices team to contribute on the EU Medical Device Registration transition program and will be working with multiple teams within the business to ensure the project is delivered successfully.

This is an ideal role for a Project Engineer with a strong desire to work as part of an experienced and enthusiastic team of engineers and looking for a solid culture of both team and personal development. It is a challenging position with opportunity for future growth.


Accountabilities:

. Overall responsibility to his/her Manager for the attainment of technical goals agreed in relation to project objectives with the appropriate level of guidance and within agreed deadlines.
. Provides support and communications applicable to the EU MDR program to ensure business partners are successful in implementation of EU MDR Requirements
. Tracks and communicates sub-stream progress, risks, timelines, etc to team members, sponsors, decision makers and business partners
. Plans and leads kick-off meetings, as required
. Liaise with other EU MDR workstreams, discuss resolution options, remove blockages
. May be given responsibility as project lead for aspects of the overall program or maintenance of aspects of the program.
. To provide assist and aid in development of custom-made devices when required.
. To adhere to the company's procedures as detailed in the SOP manual.
. Supporting regulatory submissions for existing products in strategic markets
. May handle several projects concurrently depending in the magnitude of each.
. Will meet delivery promise in terms of budget and timescales.
. Work within a small team of the Engineers within the Make To Order department which consists typically of 2, 3 or 4 Design Engineers

Qualifications, Experience and Competencies:

. Bachelor's Degree (or equivalent) in engineering or science subject, with 4 years' experience in a relevant technical area. MSc/MEng/MBA is preferred.
. An understanding of commercial considerations and creative R&D ability is essential for the job holder.
. Experience with R&D processes and procedures is required
. Experience with US and EU regulatory systems is preferred
. Strong communication & presentation skills with an ability to interact with cross-functional and remote project teams is required
. Proficient in MS Office (Project, Power Point, Excel, Word) is required

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