R&D Engineer Associate Level - Level IIThe R&D Engineer II performs design engineering functions in support of medical device product development programs across multiple therapeutic areas including cardiology, neurology, and urology. This role contributes to projects from concept through commercialization, ensuring deliverables meet customer requirements for quality, cost, and schedule performance.The Engineer II works with moderate independence to execute engineering tasks, support project deliverables assigned by the Project Manager, and communicate technical status updates to cross-functional teams. Updates may include technical feasibility, schedule impact, budget considerations, and risk to project objectives.This role also supports development of engineering processes, manufacturing readiness, and continuous improvement of product and design solutions within a regulated environment.Key ResponsibilitiesProduct Design & DevelopmentFollow the Aptyx Quality System, including all applicable SOPs and training requirementsDevelop and engineer medical devices from concept through production with little supervisionPerform hands-on product assembly and process development for catheters and other medical devicesDesign devices, components, tooling, and fixtures using SolidWorks or equivalent CAD softwareBuild prototypes and support laboratory-based development activitiesEngage with senior and principal engineers for technical guidance as neededManufacturing & Process DevelopmentDesign and develop pilot and production tooling, fixtures, equipment, and manufacturing procedures with limited supervisionSupport installation, setup, and qualification of new equipment, including development of preventive maintenance (PM) procedures as neededPerform or support equipment maintenance and coordinate re-entry to production use, escalating issues to the Technology Manager when appropriateAssess process feasibility and support manufacturing with validation planning and time studiesDevelop manufacturing methods and support product transition into full productionValidation, Testing & DocumentationDevelop and execute verification and validation activities with limited supervision, including testing and documentationPrepare engineering documentation to support the quality system, including:Test results and data analysisEngineering drawingsTest reportsEnsure compliance with good documentation practices and regulatory requirementsSupport engineering changes and updates to existing product lines as neededProject Support & CommunicationCommunicate directly with project teams and leadership regarding task status, risks, and technical challengesSupport execution of project deliverables assigned by the Project ManagerProvide input on technical feasibility, schedule, and budget impactsDemonstrate understanding of the design and development (D&D) process through execution of assigned workSupport manufacturing and product development activities through commercializationVendor & Cross-Functional CollaborationCollaborate with external vendors on sourcing of materials, components, tooling, and manufacturing processesSupport engineering teams in investigations related to customer complaints and product issuesWork cross-functionally with Quality, Manufacturing, Supply Chain, and Project Management teamsEducationBachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or related discipline requiredExperience3+ years of engineering experience in medical device development or regulated manufacturing environmentExperience with catheter-based or complex medical device development strongly preferredSkills & QualificationsProficiency in SolidWorks or equivalent CAD softwareStrong experience in hands-on prototyping and mechanical assemblyKnowledge of medical device materials and manufacturing processes (e.g., thermal bonding, PTFE processing, fixture design, etc.)Familiarity with validation (IQ/OQ/PQ), design controls, and regulated product development processesStrong analytical and problem-solving skillsExcellent verbal and written communication skillsProficiency in Microsoft Office SuiteAbility to use basic hand tools (drills, screwdrivers, wrenches, saws, etc.)Familiarity with multiple manufacturing methods used in device productionPhysical RequirementsAbility to work in both laboratory and manufacturing environments with variable conditionsFrequent use of hands, arms, and fingers for engineering and technical tasksAbility to sit, stand, and move throughout production and lab environmentsNormal vision and hearing required for communication and technical workMust be able to effectively communicate in person, electronically, and via phonePerformance ExpectationsAdherence to the Aptyx Quality System and SOP compliance requirementsTimely and accurate completion of engineering deliverables and documentationClear and proactive communication of task status, risks, and technical issuesConsistent on-time and on-budget execution of assigned workProficiency in SolidWorks and adherence to internal drawing/documentation standardsDemonstrated understanding of multiple medical device manufacturing technologies (e.g., bonding, fixture design, PTFE processing, etc.)Strong understanding of the design and development (D&D) process and its impact on project executionDemonstrated growth in technical capability, independence, and problem-solving ability