Are you a real R&D Engineer specialist? Are you ready for the next
step in your career? In this position you will be able to show both,
your engineering and management skills.
JOB DESCRIPTION
Our client is ranked among the top **Apply on the website** global
companies in the medical device outsourcing industry. The company
specializes in the design and manufacture of minimally invasive
delivery and access devices for a range of therapies.
As part of the R&D Engineering team, the Senior R&D Engineer will lead
and be an integral part of a team developing the portfolio of platform
delivery system products. This position requires a candidate with
significant product development experience in the medical device arena
and one who will be comfortable leading and developing a team to
develop products. She/he will report to the Group Leader, and the
position will be based in Galway, Ireland
_RESPONSIBILITIES_
* Lead and be an integral part of the team tasked with the
development process from concept generation through to design
verification.
* Assist in the development of intellectual property generated by
development activities.
* Ensure the application of new and existing technologies to provide
the optimum delivery system design.
* Participate in trials with physicians to provide clinically
relevant feedback on product designs.
* Provide technical feedback during frequent technical contact with
customers to optimise product design.
* Support the maintenance of product files and other relevant
documentation to comply with quality standards.
* Compile project plans and lead team to develop devices in
accordance with planned activities, budget and timelines.
_REQUIREMENTS_
* Experience in coordinating and leading Design Reviews and the
compilation of associated documentation.
* Leading the team to carry out actions in accordance with the
project plan and deliver projects through key milestone phases and
associated activities.
* Demonstrate a thorough knowledge and understanding of ISO **Apply
on the website** & FDA **Apply on the website** CFR Part **Apply on
the website** Design Control requirements.
* Proven experience of minimally invasive Medical Device design,
development and manufacturing.
* Proven experience in leading teams performing FMEA&#**Apply on the
website**;s, verifications and validations for medical devices
products and processes. Knowledge and experience with Medical Device
sterilisation processes, specifically gamma and EtO sterilisation.
* Proven experience of work with catheter technology, catheter design
and testing and catheter manufacturing a distinct advantage.
*
_EXPERIENCE WITH_ engineering tools such as DOE, SPC, and using
Minitab.
* 3D modelling experience.
* Working knowledge of biocompatible metal and/or polymer materials.
* Demonstrate a working knowledge of the required activities and
deliverables from each of the development phases.
* Availability to participate in limited travelling to meet with
customers to conduct scheduled reviews.
* Existing right to work in Europe required
BENEFITS
* Balanced salary package based upon your experience and
capabilities.
Vacancy number: **Apply on the website**
Position: ?Senior R&D / Product Development Engineer
Are you a real R&D Engineer specialist? Are you ready for the next
step in your career? In this position you will be able to show both,
your engineering and management skills.
JOB DESCRIPTION
Our client is ranked among the top **Apply on the website** global
companies in the medical device outsourcing industry. The company
specializes in the design and manufacture of minimally invasive
delivery and access devices for a range of therapies.
As part of the R&D Engineering team, the Senior R&D Engineer will lead
and be an integral part of a team developing the portfolio of platform
delivery system products. This position requires a candidate with
significant product development experience in the medical device arena
and one who will be comfortable leading and developing a team to
develop products. She/he will report to the Group Leader, and the
position will be based in Galway, Ireland
_RESPONSIBILITIES_
* Lead and be an integral part of the team tasked with the
development process from concept generation through to design
verification.
* Assist in the development of intellectual property generated by
development activities.
* Ensure the application of new and existing technologies to provide
the optimum delivery system design.
* Participate in trials with physicians to provide clinically
relevant feedback on product designs.
* Provide technical feedback during frequent technical contact with
customers to optimise product design.
* Support the maintenance of product files and other relevant
documentation to comply with quality standards.
* Compile project plans and lead team to develop devices in
accordance with planned activities, budget and timelines.
_REQUIREMENTS_
* Experience in coordinating and leading Design Reviews and the
compilation of associated documentation.
* Leading the team to carry out actions in accordance with the
project plan and deliver projects through key milestone phases and
associated activities.
* Demonstrate a thorough knowledge and understanding of ISO **Apply
on the website** & FDA **Apply on the website** CFR Part **Apply on
the website** Design Control requirements.
* Proven experience of minimally invasive Medical Device design,
development and manufacturing.
* Proven experience in leading teams performing FMEA&#**Apply on the
website**;s, verifications and validations for medical devices
products and processes. Knowledge and experience with Medical Device
sterilisation processes, specifically gamma and EtO sterilisation.
* Proven experience of work with catheter technology, catheter design
and testing and catheter manufacturing a distinct advantage.
*
_EXPERIENCE WITH_ engineering tools such as DOE, SPC, and using
Minitab.
* 3D modelling experience.
* Working knowledge of biocompatible metal and/or polymer materials.
* Demonstrate a working knowledge of the required activities and
deliverables from each of the development phases.
* Availability to participate in limited travelling to meet with
customers to conduct scheduled reviews.
* Existing right to work in Europe required
BENEFITS
* Balanced salary package based upon your experience and
capabilities.
Vacancy number: **Apply on the website**
We need : English (Good)
Type: Permanent
Payment:
Category: Others
