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Senior Design Assurance Engineer

Employer
Proclinical Staffing
Location
Galway, Republic of Ireland
Salary
Negotiable
Start date
12 Nov 2019
Closing date
26 Nov 2019

View more

Discipline
Manufacturing, Engineering
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

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.

#LI-CM3

#TechOps

Company

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Company info
Website
Telephone
0800 988 4437
Location
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom

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