I'm looking for...
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome
IE
Internet Explorer
firefox
Mozilla Firefox
opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Contact Info
Claire Kenny
Life Science

+353 1 507 9287
claire.kenny@lifescience.ie
Connect with me on
Process Engineer
Limerick
Quality Engineer
Dublin South
QA Specialist
Dublin
Quality Engineer
Limerick
CTO
Galway
API Purchaser
Dublin
CSV Engineer
Dublin
QC Trainer
Cork
R&D Engineer
Dublin
R&D Engineer
Dublin
Program Manager
Westmeath
Consultant
Cork
Biostatistician
Dublin City Centre
Risk Manager
Dublin
Administration Support
Dublin North
Quality Manager
Dublin South
Senior Social Work Practitioner
Republic of Ireland
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to applications@lifescience.ie
Details

Senior Systems Engineer / Medical Design Engineer


Reference:A005658 Location: Limerick
Qualification:DegreeExperience:See description
Job Type:PermanentSalary: Not Disclosed

A respected Medical Device client in Limerick is looking for a highly talented Senior Systems Engineer / Medical Design Engineer to take responsibility for providing their systems knowledge to further medical device development efforts.

Job Description
As part of a team, you will be to the forefront of creating and developing specialized devices, software solutions and systems to help others. The workplace you will be joining provides you with cutting edge technology and a creative environment to be inspired to tap into your inner genius.
The client is looking for a highly talented Senior Systems Engineer / Medical Design Engineer to take responsibility for providing their systems knowledge to further development efforts for a Medication Management Solution (MMS) business unit segment focusing initially on infusion pumps. The Senior Systems Engineer will need to demonstrate a good understanding of fundamental/traditional systems engineering principles, procedures and techniques across the spectrum to connect various functional elements related to the development and through life of electronic and software systems and subsystems. The suitable candidate has a background in the medical industry with design engineering and regulatory experience. The suitable candidate should also be able to analyse customer/user needs to produce detailed requirements specifications and systems architecture for the creation of new or enhancement of existing hardware and software products that may affect multiple systems.
You are the one who can make the difference. Join us and be a crucial part of advancing the world of health!

Be the Senior Systems Engineer:
• Demonstrate knowledge of advanced system-level technology and systems development process.
• Demonstrate knowledge of medical product design.
• Coordinating and influence product development across multiple disciplines and locations.
• Serve as a key resource to examine systems behaviour issues and bring resolution for existing infusion products.
• Provide technical support to a wide range of systems-level problems pertaining to specific MMS programs and projects.
• Making customers/stakeholders and their needs a primary focus of one’s actions; developing and sustaining productive business relationships on a global front.
• Consistently apply systems engineering techniques such as requirements synthesis, decomposition, use case modelling, traceability, risk management, verification and validation, product architecture, etc.

Be Qualified:
• Degree qualified (or equivalent) ideally in biomedical, mechatronics, mechanical, electrical, electronics, software or systems engineering.
• Demonstrable track record in professional work experience with 5+ years in the medical industry.
• Ability to Support Regulatory Affairs with engineering input for design related submissions & resubmissions (510K/Notifications).
• To be responsible for the completion of risk benefit analysis documentation including documenting background of devices types, use case, harms, treatments, benefits, competitor devices, clinical studies, biocompatibility & materials and literature review.
• Maintain Risk management files for existing devices (i.e. dFMEA, Risk Benefit Analysis) and take input from Clinical Evidence Reports (CER).
• Knowledge of MDR/MDD/AIMD, global medical device/FDA regulations, ISO 14971, ISO13485, device remediation, UDI & device traceability, Sterilization, Material Biocompatibility, Clinical Trials, Agile PLM is preferred.
• Experience in DFSS (Design for Six Sigma) knowledge and experience is preferred.
• Understanding agile development methodologies and scrum practices are desirable.
• Experience with Requirements Management tools (DOORS, etc.) and configuration tools (TFS, etc.) is a plus.
• Knowledge of model-based systems engineering (MBSE), design methods using SysML or UML, and modelling tools (Rhapsody, Enterprise Architect, etc.) is a plus.
• Strong technical writing skills, producing requirements specifications, risk reports, and test procedures, and;
• Experience in traditional systems engineering development, architectural design and/or project engineering.

If you would like further Information you can contact the recruiter directly:

Claire Kenny | Tel: +353 (0) 1 507 9287