Research & Development Engineer (Drug Coated Combination Devices)

HERO

Job Detail

Location Limerick
Salary Negotiable
Posted
Role Type Permanent
Contact Laura Neary
email recruit@hero.ie

Research & Development Engineer (Drug Coated Combination Devices)

Apply Now

Job ID: JOB-11997
Research & Development Engineer (Drug Coated Combination Devices)

Reporting to: Senior Research & Development Engineer/Research & Development Manager

Responsibilities:

Perform Duties of Research & Development Engineer:

  • This role will have an emphasis on Drug Containing Part of Vascular Drug-Device Combination Products. There is specific emphasis on qualification of Active Pharmaceutical Ingredient (API) supplies, the creation of final specifications for drug coated devices and execution of design verification of the Drug Containing Part.
  • Qualify new API suppliers.
  • Design development, prototyping, test method design, design evaluation, design reviews, de sign specifications, design verification and validation, design protocols and reports, transfer to production activities in a timely effective manner.
  • Product testing and evaluation, completion of test reports to support design selection.
  • Preparation and presentation of design reviews.
  • Product and project risk analysis and risk management.
  • Work with Process Development Engineering to introduce/develop new equipment and production processes as required for any new manufacturing techniques.
  • Source new materials components and equipment.
  • Development of component specifications, inspection methods, bills of materials and manufacturing processes.
  • Introduction of new equipment, materials and technologies.
  • Work closely with Key Opinion Leaders (KOL’s), physicians and product managers to develop innovative medical devices to improve patient care.
  • Project lead for assigned research & development projects including technical and project management responsibly.
  • Manage and drive project tasks to ensure timely completion of project milestones.
  • Work closely with cross functional groups to achieve project and company goals.
  • Product performance evaluations.
  • Contribute to innovation and creativity within team through filing of disclosures and patents.
  • Hold regular project meetings and document minutes and actions.
  • Ensure project milestones are achieved to meet business metrics.
  • Compliance with Quality, Regulatory and company policies and systems.

Communications:

  • Regular communication to cross-functional teams, senior management and business unit leaders.
  • Project status communications and reporting.
  • Remain on the forefront of emerging industry practices.
  • Educating oneself in the medical area for which the new devices are being developed in order to have an appreciation for what needs to be achieved with these products.
  • Support other cross functional groups to deliver company goals.
  • Ensure that the clients’ Code of Conduct is considered in all business matters.

Qualifications / Requirements:

  • Third level degree in Chemistry, Mechanical, Biomedical, Design, Chemical Engineering or similar discipline.
  • 2 years’ experience in the design or qualification of drug products and/or drug/device combination products.
  • Knowledge of medical device quality & regulatory systems, medical device directives and applicable pharmaceutical regulatory requirements.
  • ICH Guidelines
  • Control of Components Drug Products
  • 21 CFR Part 4, 211
  • ISO13485 and FDA CFR 820
  • EU Medical Device Regulation 2017/745.
  • Project planning skills.
  • Execution of project in a timely effective manner.
  • Knowledge of anatomy and physiology.
  • Good mechanical design and understanding of engineering fundamentals with extensive medical device materials knowledge.
  • Manufacturing design and process understanding.
  • Strong technical writer.
  • Team Player with ability to develop strong working relationships.
  • Strong communication and inter-personal skills.
  • Good problem solving skills.
  • Highly motivated individual, self-starter with a passion for excellence.
  • Must be able to work in a fast paced environment.
  • Willingness and availability to travel on company business.

For further information on this role please contact Laura Neary on 086 773 8651/ recruit@hero.ie

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

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Laura Neary

JOB-11997

Apply Now

Research & Development Engineer (Drug Coated Combination Devices)

Laura Neary

Role Type Permanent
Contact Laura Neary
email recruit@hero.ie
mobile +353 86 773 86 51
linkedIn profile click here

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