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February 19 2018

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Job Offer: Senior Design Assurance Engineer - Medical Device:Sigmar Recruitment

Job description:

Senior Design Assurance Engineer - Medical Device

Sigmar Recruitment

   » Galway / Galway city / Nationwide
   » Negotiable
   » Permanent full-time
   » Updated 20/01/2018
   » James Porter this job is expired SaveSave Apply Now

Job detail

The Senior Design Assurance Engineer provides input to our development teams in the design of highly complex medical devices

TheSeniorDesign Assurance Engineer provides input to our development teams in the design of highly complex medical devices. They ensure that compliance to customer and regulatory requirements is demonstrated and help to ensure prosperous transfer of the design to manufacturing. They are responsible for accurate, independent evaluation of Design History File documentation and overall Quality System compliance
Key Job The main responsibilities are:
* Design Control
* Risk management / ISO14971
* Familiar with product specific requirements - ISO555 PART 1 (standard for intravascular catheters)
* Plans, conducts and executes design assurance activities requiring judgment in the independent evaluation
* Works closely with product development engineering and the client team to establish the system design specifications and product requirements.
* Works closely with design, development, quality, regulatory, and the client team
* Performs and documents all engineering studies and reports to satisfy the master verification plan
* Plans, coordinates and executes design verification testing to directly support the master verification plan
* Participates with the engineering team to establish and review the design FMEA
* Routinely provides design assurance guidance and direction to engineers and/or technicians for the duration of a project assignment
* Possesses a comprehensive knowledge of ISO10555 principles, design FMEA practices, and any industry standards
* Support various QA/RA activities including quality management, system reviews, audits, etc.
* Evaluation of new products, assuring the safety and efficacy of the devices
* Design verification and shelf life protocols / reports review.
* Root cause investigations; drive problem solving efforts for quality issues
* Generate and approve change requests

General Job requirements:
Candidates must havea minimum of5 years of significant practice with a Bachelors degree or higher in Engineering, or a related discipline.
Must be able to work independently and as a member of a cross-functional team, to multi-task and do what Information technology takes to meet high expectations and tight deadlines. Will be working on highly visible projects in high-pressure situations.
Must have good written & oral communication expertise and the capability to communicate appropriately with different engineering teams, Product Management, vendors and partners, and customers.
Must be able to travel occasionally to meet with customers / project teams
To apply for this position Contact Us by James Porter at Sigmar RecruitmentT: +353 91 455305E:
All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent

Ref: JPSnrDAEng
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Sigmar Recruitment


   » 01 4744 600


Job Category: Customer Service [ View All Customer Service Jobs ]
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Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Galway , Other
Company Type Employer
Post Date: 01/20/2018 / Viewed 26 times
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Company: Sigmar Recruitment
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