Location: Balybrit, Galway
Benefits: Career progression, an excellent salary, **Apply on the
website**days annual leave, PRSA and stock options.
Company:
My client is a privately held clinical stage company who are dedicated
to developing a minimally invasive transcatheter solution. You will
get the opportunity to work with experts in the structural heart field
leading a team of Engineers.
Responsibilities:
Lead key elements of the Design Review process in compliance to
internal procedures including EU and FDA requirements
Work with R&D to establish design specifications and product
requirements.
Lead key elements of the risk management process and preparation of
risk management
In conjunction with the R&D/Operations teams identify product testing
required and write design verification and validation plans, protocols
and reports
Generation and/or review of quality and technical documentation /
change requests to support design activities.
Support various QA/RA activities including quality management, system
reviews, internal & vendor audits
Supports regulatory compliance / submission process.
Requirements:
Possess Degree / Post-Grad in engineering, biomedical or science
degree.
4+ years&#**Apply on the website**; experience in a medical device
manufacturing environment with direct experience in a design assurance
role.
Working knowledge of the Medical Device Directive (**Apply on the
website**/**Apply on the website**/EEC)/Medical Device Regulation
**Apply on the website**/**Apply on the website** and FDA requirements
including Quality System Regulation
Knowledge and demonstrated practice of risk management methodologies
as per EN ISO**Apply on the website**
Experience in mentoring/guiding team members.
If you are interested in applying and hearing more about this new
opportunity forward a copy of your up to date CV or contact the
details mentioned.
Looking forward to hearing from you
To find out more about Real please visit
Real Staffing, a trading division of SThree Partnership LLP is acting
as an Employment Agency in relation to this vacancy| Registered office
| 1st Floor, **Apply on the website** King William Street, London,
EC4N 7BE, United Kingdom | Partnership Number | OC(phone number
removed) England and Wales Job title: Senior Design Assurance Engineer
Location: Balybrit, Galway
Benefits: Career progression, an excellent salary, **Apply on the
website**days annual leave, PRSA and stock options.
Company:
My client is a privately held clinical stage company who are dedicated
to developing a minimally invasive transcatheter solution. You will
get the opportunity to work with experts in the structural heart field
leading a team of Engineers.
Responsibilities:
Lead key elements of the Design Review process in compliance to
internal procedures including EU and FDA requirements
Work with R&D to establish design specifications and product
requirements.
Lead key elements of the risk management process and preparation of
risk management
In conjunction with the R&D/Operations teams identify product testing
required and write design verification and validation plans, protocols
and reports
Generation and/or review of quality and technical documentation /
change requests to support design activities.
Support various QA/RA activities including quality management, system
reviews, internal & vendor audits
Supports regulatory compliance / submission process.
Requirements:
Possess Degree / Post-Grad in engineering, biomedical or science
degree.
4+ years&#**Apply on the website**; experience in a medical device
manufacturing environment with direct experience in a design assurance
role.
Working knowledge of the Medical Device Directive (**Apply on the
website**/**Apply on the website**/EEC)/Medical Device Regulation
**Apply on the website**/**Apply on the website** and FDA requirements
including Quality System Regulation
Knowledge and demonstrated practice of risk management methodologies
as per EN ISO**Apply on the website**
Experience in mentoring/guiding team members.
If you are interested in applying and hearing more about this new
opportunity forward a copy of your up to date CV or contact the
details mentioned.
Looking forward to hearing from you
To find out more about Real please visit
Real Staffing, a trading division of SThree Partnership LLP is acting
as an Employment Agency in relation to this vacancy| Registered office
| 1st Floor, **Apply on the website** King William Street, London,
EC4N 7BE, United Kingdom | Partnership Number | OC(phone number
removed) England and Wales
We need : English (Good)
Type: Permanent
Payment:
Category: Others
