CareerWise Recruitment
Location
County Cork, Co. Cork
Location type
Hybrid
Employment type
Full time
Job type
Permanent
Apply now
Apply now

A Lead Design Engineer is required by CareerWise Recruitment to join our Cork based award winning med device client. This is a fantastic opportunity to join a friendly, professional core team developing novel IV infusion devices for launch into global markets.

ROLE:

* Lead the development and evolution of both current and future products.
* Execute design controls activities (design verification, design validation and design transfer) per 21 CFR.
* Leading the team and working with external partners and resources as required. 
* Develop concepts (CAD) and prototypes (3D print) of novel medical devices.
* Generate design verification/validation protocols and reports.
* Conduct risk management activities per ISO 14971.
* Lead design reviews, offering valuable insights and suggestions to optimise product performance and manufacturability.
* Provide support for manufacturing of new products with tooling, product design and process validation.
* Prepare and execute of test methods (lab and clinical) as part of design verification.
* Responsible for technical documentation and support to acquire regulatory certifications to launch the products in the target markets  - US/EU etc
* Work within a cross functional team to ensure project success.
* Identify, lead and contribute to the creation of best practices, articles, and white papers.

 

REQUIREMENTS:

* Bachelor of Science in Engineering, Mechanical Engineering/Biomedical and 5-10  years’ experience working with a med device company whose products and processes are FDA regulated.
* Experience in design and development of medical devices per ISO 13485, especially design verification and validation.
* Knowledge of medical device regulations (MDR and FDA) and experience with ISO 14971 and IEC 62366 is an advantage.
* Good technical capabilities and initiative with knowledge of engineering software.
* Excellent problem-solving skills and a passion for creating innovative solutions.

Please call Diarmuid Buckley today for further information on 021- 4355432 or email: dbuckley@careerwise.ie

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. 

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

 

 

 

Please call Diarmuid Buckley today for further information on 021- 4355432 or email: dbuckley@careerwise.ie

Important Dates
Posted on
09 July, 2024
Application deadline
08 August, 2024
Reference number
JOB-16049

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