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Vacancy Details

Engineering & Technical

Principal R&D Engineer - Galway - 103384

Contract Type: Permanent
Sector:
Location: Galway
Date: 6/03/2019
Job Reference: 103384
Contact Name: Bimi Felix
Contact Email: bimi@hero.ie

Job Description

Principal R&D Engineer - Galway - 103384
Principal R&D Engineer - Medical Device

Our client, a global medical device company in Galway is is seeking a highly motivated and experienced Principal R&D Engineer to join the Structural Heart R&D team.

Job Purpose

  • Responsible for design and development of next-generation minimally invasive medical devices for the treatment of valvular heart disease. Successful candidate will work independently, or as a member of a team within a dynamic New Product Development organisation specialized in transcatheter heart valve system development for commercialization in all major global healthcare markets.
  • Independently, or as a member of a team, develops, directs, and executes plans for a major segment of complex projects
  • Under limited supervision/guidance, compiles, analyzes, and reports operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials.

Key Responsibilities

  • Lead engineering design, development and support of next generation and current generation transcatheter heart valve products
  • Apply Mechanical and Biomedical Engineering knowledge to the design, development and assessment of prosthetic heart valves
  • Create/develop technical capabilities and expertise related to the design and testing of heart valve technology
  • Develop hydrodynamic and fatigue test methods and characterisation techniques to evaluate performance of valve prototypes
  • Perform necessary tasks to successfully translate designs from proof of concept through commercialization including:
    • Ensure review of existing research, device concepts and data.
    • Generate valve design concepts, build and evaluate prototypes.
    • In conjunction with product planning / marketing, collaborate with leading physicians and experts for the purpose of identifying and clarifying customer needs, plans, goals, and progress.
    • Prepare trade-off studies and implement alternative approaches to mitigate schedule delays and identify areas that require additional investigation.
    • Solve problems at the component through system level
    • Conduct tests utilizing existing test protocols, or develop new ones as needed and generate related written reports
    • Performs data analysis (statistical and practical) and develops appropriate action plans based upon such analysis.
    • Participate in the specification and direct completion of specific verification/validation testing and analyses required that satisfy both regulatory and internal requirements.
    • Document concepts, designs and design modifications in accordance with internal policies, industry standards and FDA requirements.
  • Coordinate with outside consultants and clinicians to ensure testing and analyses required to fully qualify and verify device designs are appropriately representative of expected use conditions.
  • Work closely with team members and internal partners in Regulatory, Quality, Manufacturing, Marketing and other departments to deliver project objectives
  • Provide clear and regular technical direction to personnel assigned to a project
  • Maintain technical knowledge current with advancing technology related to cardiac valve prostheses and associated technologies in addition to knowledge of competitive technologies
  • Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers related to materials, manufacturing processes and design
  • Support manufacturing and quality groups for improvements to existing products in the areas of quality enhancement, product cost and product performance.
  • Prepare or direct the preparation of oral and written reports of current status, progress and status of total project, as required by the customer, project or department Management.

Qualifications

A bachelor's degree in Mechanical Engineering or Biomedical Engineering is required. An advanced degree is a distinct advantage.

  • 9+ years experience with BS Degree
  • 7+ years experience with MS Degree
  • 4+ years experience with PhD

Position requires relevant mechanical/biomedical engineering experience to include heart valve development, exposure to design of experiments, specification development, and prototyping. Prior experience in an interventional, vascular or cardiac surgery arena a plus, especially involving prosthetic tissues and catheter based technologies.

Required Skills:

  • Experience in the design and development of valve prostheses and associated processes are required
  • Experience with medical device testing of vascular prostheses and/or catheter delivery systems a plus
  • Understanding and extensive application of technical principles, theories, and design concepts in implantable products
  • Good understanding of the Human Anatomy and cardiovascular physiology is strongly desired
  • In depth understanding of fluid mechanics and computational fluid dynamics (CFD) particle image velocimetry is strongly desired
  • Broad, working knowledge of manufacturing process for medical devices, design control and Quality Systems.

For further information on this Senior R&D Engineer role in Galway please contact Bimi Felix on 086 8395533 / bimi@hero.ie

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