Candidate requirements
* Bachelor of Science in Engineering, Mechanical Engineering/Biomedical and 5+ years' experience working for a medical device company whose products and processes are FDA/EU regulated.
* Experience in design and development of medical devices per ISO 13485 & FDA 21 CFR Part 820, especially design verification and validation.
* Knowledge of medical device regulations (MDR and FDA) and experience with risk management according to ISO 14971 and IEC 62366 is an advantage.
* Good technical capabilities and initiative, with knowledge of engineering and statistical software.
* Excellent problem-solving skills and a passion for creating innovative solutions.
* Demonstrate ownership of critical work activities and ability to prioritise these activities when required.
* Experience in generating technical files and regulatory documentation associated with medical devices, such as risk analysis, dFMEA, DIOVV and related documents.
Responsibilities for this role
* Research and translate voice of customer and voice of patient information into a series of user needs.
* Develop concepts (CAD) and prototypes (3D print) of novel medical devices.
* Contribute to design reviews, offering valuable insights and suggestions to optimise product performance and manufacturability.
* Provide support for manufacturing of new products with tooling, product design and process development and validation.
* Analyse data sets using appropriate statistical techniques and generate reports to summarise the information.
* Responsible for on-site laboratory testing.
* Manage off-site testing labs and test houses required for external testing.
* Preparation of test methods, execution of test methods and data collection in support of engineering projects.
* Analyse data and prepare reports to summarise results.
* Communicate findings and collaborate with cross-functional teams.
* Execute design controls activities (design verification, design validation and design transfer) per FDA 21 CFR Part 820.
* Generate design verification/validation protocols and reports.
* Conduct risk management activities per ISO 14971.
* Responsible for technical documentation and support to acquire regulatory certifications to launch the products in the target markets.
* Identify, lead and contribute to the creation of best practices, articles, and white papers.
* Responsible for creation of quality system and regulatory documentation, such as user requirements specifications, design inputs and outputs.
* Supporting the quality management system in closing out CAPA, complaints and change requests.
* Support the submission of documentation to national authorities for regulatory approval.
Skills and experience
* Design, Biomedical Engineering, Mechanical Engineering, Science, Infusion Devices, CAD, Development, MDR, FDA, 3D Printing, Manufacturing, New Products, Process Validation, Process Development, verification, Validation
Job details
* Seniority level: Entry level
* Employment type: Full-time
* Job function: Design
* Industries: Medical Equipment Manufacturing
Adecco Ireland is acting as an Employment Agency in relation to this vacancy.
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