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Senior Design Assurance Engineer
- Permanent
- Validation
- Ireland
This vacancy has now expired. Please see similar roles below...
A leading medical device company is advertising a vacancy for a Senior Design Assurance Engineer to be based in their Irish office. The organisation utilises innovative technology to develop and improve instruments that concentrate on enhancing the performance of vascular stents. This is an exciting opportunity to work with a dynamic company who pride themselves on their outstanding work in their field.
Job Responsibilities:
- Providing Design Assurance input to R&D project teams for designated projects.
- Understanding the Regulatory requirements for device developments and providing input to projects to encompass these requirements.
- Participating in the generation of Design Input/Output documents.
- Participating in specification development in relation to design input development.
- Driving the risk management activities for designated projects and design changes.
- Designing, developing, and validating test methods as required to support development
- programs.
- Developing and maintaining design verification and validation plans, protocols, and reports.
- Supporting R&D in the preparation and delivery of Design Reviews and associated checklists.
- Supporting the conduct of non-clinical studies at third party facilities in conjunction with R&D
- department.
- Establishing and maintaining the Design History File and associated documents.
- Providing QA support to R&D for equipment management.
- Executing assigned aspects of the project, as required.
- Working within the quality system and ensuring that the quality policy and company systems
- and procedures are complied with in line with the Medical Device Directive 93/42/EEC,
- Medical Device Directive 2007/47/EC, MDR 2017/745, FDA Quality System Regulations 21
- CFR Part 820, FDA GLP Regulation 21 CFR 58, ISO 13485, ISO 14971, and Japanese Ministerial
- Ordinance # 169.
- Supporting the development/evolution of the Design Control, Risk Management, and
- associated systems, to encompass new product development technologies.
Skills and Requirements:
- A degree level qualification in Engineering, Science, QA, or related field is required.
- A minimum of five/three years' relevant experience in the medical device or pharmaceutical
- industry, preferably with Stent and Stent Coating technology experience.
- An understanding of ISO 13485, ISO 14971, and FDA QSRs is a prerequisite.
- Familiarity with statistics, validation, and physical testing is required.
- Experience in DES is an advantage.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Caleb Mensah at +44 203 854 1080 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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