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R&D Analytical Chemist

  • Sector: Engineering
  • Contact: Rhys Joyce
  • Contact Email: rhys.joyce@collinsmcnicholas.ie
  • Job Ref: 17798

An exciting opportunity to join a world leader in Medical Device Manufacturing as a R&D Analytical Chemist.


Key Responsibilities

  • Lead analytical testing and capability for the development and commercial phases of transcatheter heart valve products. Develop internal and regulatory led analytical methods and characterisation techniques to evaluate performance of valve prototypes
  • Create/develop technical capabilities and expertise related to the development of novel processes and validation techniques for the fixation and sterilisation phases of heart valve technology
  • Perform necessary tasks to successfully develop products from proof of concept through commercialization including:
    • Ensure review of existing research, device concepts and data.
    • 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
  • 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 Chemistry is required. An advanced degree (M.Sc. or Ph.D. in Chemistry or Bio-Organic Chemistry) is a distinct advantage.
  • Position requires relevant tissue engineering experience to include materials and solutions development, exposure to design of experiments, specification development, and test method development.
  • 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
  • R&D, design of experiments, process validation, SOP, Scale-up, GMP adaptation
  • Process improvement, product development, technology transfer in compliance with ISO requirements of a Class III medical device
  • Bioburden and sterility validation of a Class III medical device
  • Biomolecules modification: proteins, peptides, oligonucleotides, ECM polymers, CNTs and liposomes
  • NMR, HRMS, IR, CD, UV-Vis and fluorescence spectroscopy, HPLC, rheology and DLS & zeta potential 
  • Bright field and fluorescence microscopy, SEM, AFM and TEM
  • Cell culture, receptor staining and ELISA
  • Broad, working knowledge of manufacturing process for medical devices, design control and Quality Systems.

For a confidential discussion and more information on the role please contact Rhys Joyce.

091-706718

rhys.joyce@collinsmcnicholas.ie