R&D Engineer II

Description: R&D Engineer IFull Onsite Carlsbad, CAJob PurposeDevelops products, materials, processes, and equipment for projects of moderate complexity. Under limited supervision, plans and executes engineering activities to support product development, sustaining engineering, manufacturing, and process improvement initiatives. Compiles, analyses, and reports operational, test, and research data to establish performance standards for new or modified products, processes, and materials.Key Responsibilities Contribute as a core team member on product development, sustaining engineering, and process improvement projects. Support product design activities, including concept development, design modifications, prototyping, and engineering documentation. Plan and execute engineering studies, experiments, and testing activities to support design and process decisions. Create and maintain engineering documentation, including specifications, protocols, reports, drawings, and design records. Utilise CAD software (e.g., SolidWorks) to support product, fixture, tooling, and test equipment design activities as required. Design, procure, and coordinate fabrication of tooling, fixtures, and test equipment. Investigate technical issues related to product design, materials, manufacturing processes, and product performance. Analyse test results, identify trends, and formulate data-driven conclusions and recommendations. Support engineering change activities and implementation of design or process improvements. Collaborate with Manufacturing, Quality, Regulatory, Clinical, and Marketing teams to achieve project objectives. Support development and maintenance of technical files, risk management documentation, and design history records. Generate innovative ideas and contribute to intellectual property and product improvement initiatives. Plan and manage individual work activities to meet project milestones and deliverables. Provide technical support and guidance to technicians and other team members as required. Demonstrate knowledge of Product Development Process (PDP) and Technology/Product Development (TPD) systems through delivery of high-quality engineering outputs. Quality Systems Duties And ResponsibilitiesBuild quality into all aspects of work by ensuring compliance with applicable quality system requirements, design control procedures, documentation standards, and regulatory requirements.QualificationsBachelor's Degree in Mechanical Engineering, Biomedical Engineering, Product Design, Materials Engineering, or a related engineering discipline. 0-2 years' experience with in the Medical Device Industry. Experience supporting product development, sustaining engineering, or manufacturing projects preferred. Strong analytical and problem-solving skills. Effective communication and technical writing skills. Ability to work independently and collaboratively within cross-functional teams. Additional Job-Specific RequirementsWorking knowledge of CAD software (SolidWorks preferred) is desirable. Ability to interpret and create technical drawings and engineering documentation. Experience analysing and presenting technical data. Understanding of engineering fundamentals, design principles, and manufacturing processes. Strong organisational skills with the ability to manage multiple priorities. Experience within a regulated industry, particularly medical devices, is advantageous. Familiarity with Design Control, Risk Management, and Engineering Change processes is preferred. Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint.