Job Description
Our client, a young innovative Medtech company with strong investment, now seeks a Research & Development Engineer for the development and commercialization of their novel drug delivery technology. This is a permanent role, based in the greater Dublin area and will report to a Principal R&D Engineer.
This hire will work on the company’s pilot stage Medtech device, supporting the product development team through product design development, verification, validation and regulatory approval.
The successful candidate will work on high-fidelity prototypes, development of test methods and associated jigs and fixturing, writing of testing protocols & reports. Proven documentation skills and adherence to ISO 13485 is required.
This role will appeal to an ambitious R&D Engineer, who is eager to learn and rapidly grow their knowledge and experience in the Medtech industry. Ability to work with an innovative and collaborative team in a fast-paced environment is fundamental to success.
Responsibilities of R&D Engineer:
Provide assistance with and input into technical solutions and/or refinements to the product design in line with a high-volume manufacturing approach, user needs and design inputs
Assist in the production of high-fidelity prototypes for internal and external evaluation
Assistance with development of test methods and associated jigs and fixturing, writing of testing protocols & reports
Conduct activities within a quality management system following 21CFR820 QSR.
Generate all required documents to support design control and risk assessment requirements (21 CFR 820, ISO 13485 and ISO 14971)
Proven ability to work with a close-nit, cross-functional team, including Industrial Design, Packaging, Manufacturing, Engineering, Biocompatibility, Quality, and Regulatory.
Input into the selection and management of outside vendors.
Assistance with laboratory/workshop functions, health & safety policies, installations and operations
Assistance with selection and purchasing of technical equipment
Requirements for R&D Engineer:
BSc, BEng, M.Eng. Degree in Mechanical or Biomedical Engineering, or related discipline
18+ months relevant R&D experience in medical device design/product development is preferred.
Minimum of 1 year experience working with Design Dossiers, Technical Files, Product Specifications, Design FMEAs, Design Verification Protocols and Reports.
Proficiency with 3D CAD software (PTC Creo or similar) and working knowledge and experience with diverse prototyping techniques (including 3D printing).
Appetite to learn new skills and techniques, solve challenging technical problems, and work across multiple functional areas as part of a multidisciplinary team
Effective communication skills (both written and verbal).
Strong organizational skills and attention to detail.
Please phone Larry on +353 1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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