Excellent opportunity to join a Medical Device company in Galway as an Analytical Chemist II
An Analytical Chemist II is required for a global Medical Device company based in Galway.
Lead analytical testing and capability for the development and commercial phases of medical device products. Develop internal and regulatory led analytical methods and characterisation techniques to evaluate performance of device prototypes
Create/develop technical capabilities and expertise related to the development of novel processes and validation techniques for the fixation and sterilisation phases of device technology
Perform necessary tasks to successfully develop products from proof of concept through commercialization
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.
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 processes for medical devices, design control and Quality Systems.
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 is a plus, especially involving prosthetic tissues and catheter based technologies.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.