Job Description
Our client, a young innovative Medtech company with strong investment, now seeks a highly skilled and experienced Principal 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.
This hire will work on the company’s pilot stage device through Product Development Life Cycle, i.e. through design development, verification, validation and regulatory approval. The key deliverable for this role will be on product design, development, testing and approaches to high-volume manufacture (i.e., DOE, PFMEA, DFM, etc).
The ideal candidate will be an experienced Senior R&D Mechanical / Biomedical / Medtech Engineer with prior experience in the development and manufacture of drug delivery technology. Additionally, this hire will be experienced and show proven ability in working closely with peers and cross-functional teams, including outsourced CDMO / CMOs.
This role will appeal to an experienced development engineer who enjoys working in a fast-paced, innovative collaborative environment, navigating the challenges associated with novel technology for Medtech industry (ISO 13485).
Responsibilities of Principal R&D Engineer:
Developing of innovative technical solutions and/or refinements to the product in-line with a high-volume manufacturing approach, user needs and design inputs
Creation of detailed component and finished device assembly drawings/specifications
Leading the development and production (including using rapid prototyping methods) of high-fidelity prototypes of the product for internal and external testing
Developing of test methods and associated jigs and fixturing, generate and maintain design specifications, write protocols & reports, conduct design verifications & validations and FMEA’s in line with ISO 14971 Risk Management
Conduct activities within a quality management system following 21CFR820 Quality System Regulation
Generate all required documents to support design control and risk assessment requirements (21 CFR 820, ISO 13485 and ISO 14971)
Work closely with the multidisciplinary team and external consultants with specialties spanning all areas of Medtech development path towards commercialisation.
Input into the selection and management of outside vendors.
Provide technical and project leadership for R&D activities
Assistance with laboratory/workshop functions, health & safety policies, installations and operations
Assistance with selection and purchasing of technical equipment
Site-visits to suppliers and subcontractors from time to time
Associated travel from time to time to conferences and/or industry events
Requirements for Senior R&D Engineer:
BSc, BEng, M.Eng. Degree in Mechanical or Biomedical Engineering, or related discipline
5+ years of related experience in medical device design/product development. Prior experience with drug delivery devices and products highly preferred
Strong design and technical ability based on a broad and deep knowledge of fundamental engineering principles.
Demonstrable technical capabilities 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).
Detailed knowledge of Design Controls and FDA, GMP, QSR and ISO 13485 requirements and experience working within a quality management system.
Willingness 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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