Job Detail

Location Galway
Salary Negotiable
Posted
Role Type Permanent
Contact Amanda Reynolds
email technical@hero.ie

Senior Design Assurance Engineer

Job ID: JOB-11445

Senior Design Assurance Engineer

My exciting start up medical device client are recruiting for a Senior Design Assurance Engineer to join their growing team in Galway.

DUTIES & RESPONSIBILITIES

  • Managing the Design Verification and Validation function; defining verification and validation techniques, risk management, statistical techniques and compliance to regulatory requirements
  • Responsible for the compilation of design verification/validation protocols, reports and design design/quality documentation supporting product development/sustaining engineering projects
  • Working closely with contract manufacturer to ensure complete verification and validation for the entire design system including any subsequent design changes
  • Management of the risk management activities
  • Completing work assignments under limited supervision/guidance
  • Interfacing with R&D, Regulatory Affairs, Clinical Marketing, Manufacturing in a project team environment providing technical and Quality systems input to the team
  • Familiarity with requirements and procedures that govern the Product Development
  • Identifying and resolves moderately complex exceptions to work assignments
  • Participating in Simulated Use/Bench Testing as part of both early development projects and during execution of design verification/validation studies
  • Experienced in test method development and validation
  • Excellent analytical and problem-solving abilities. Analyses, draws conclusions and makes appropriate decisions from risk management activities and test data
  • Updating Quality policies to ensure compliance with Product Development needs and relay this information to the Product Development Group
  • Keep abreast of changes in domestic and international Quality Systems regulations and guidelines, and advise Key staff of compliance/non-compliance with FDA requirements for Design Verification and Validation and current international regulations, policies and EC directives
  • Providing both quality and technical input to the design reviews, project development/design change plans, risk management, design verification/validation protocols and reports
  • Availability to participate in limited travelling to meet with customers to conduct scheduled reviews.
  • Other such duties as may be assigned on behalf of the Company from time to time

EDUCATION/EXPERIENCE

  • Degree in Engineering/Science or related discipline
  • Minimum 5 years’ experience in a relevant role in the medical device industry,
  • Advanced knowledge and experience with implementing ISO14971 Risk Management Systems,
  • Advanced knowledge and experience with medical device regulated design control systems including advanced knowledge of design verification and validation methods
  • Highly developed written and verbal communication skills
  • Proven ability of working in a cross-functional team environment,
  • Knowledge and practical experience with the use of statistical techniques in design verification and validation
  • Strong communication and presentation skills are desirable
  • Thinks Critically and Makes Sound Decisions
  • Collaborates and Creates Alignment as a Team member
  • Works with transparency

For further information on this Senior Design Assurance Engineer role in Galway please contact Amanda Reynolds on 0860468858/ technical@hero.ie

 

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

 

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Amanda Reynolds

JOB-11445

Senior Design Assurance Engineer

Amanda Reynolds

Role Type Permanent
Contact Amanda Reynolds
email technical@hero.ie
mobile +353 86 046 88 58
linkedIn profile click here

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