R&D Engineer Level II-Senior

Job Description

Job Description

The Engineer II – Senior R&D Engineer performs design engineering and technical leadership within the Development organization, supporting the development of Class II and Class III medical devices across multiple therapeutic areas including cardiology, neurology, and urology.This role supports or leads cross-functional project teams from concept through commercialization, ensuring delivery of customer requirements for quality, cost, and timeline objectives. The engineer contributes to or leads technical execution, communicates project status, and ensures engineering deliverables align with regulatory and quality system requirements.Engineer II-level employees operate with moderate supervision, while Senior Engineers lead technical execution, mentor team members, and drive project outcomes with minimal oversight.Key ResponsibilitiesProduct Development & Engineering ExecutionFollow Aptyx Quality System, including all applicable SOPs and training requirementsDesign and develop medical devices from concept through production with increasing independence based on level (Engineer II vs Senior)Lead or support hands-on development of catheters and other medical devices, including assembly and prototypingDesign components, devices, tooling, and fixtures using SolidWorks or equivalent CAD softwareBuild prototypes and support laboratory development activitiesDevelop and refine manufacturing methods, processes, and procedures through commercializationProcess Development & Manufacturing SupportDevelop pilot and production tooling, fixtures, equipment, and assembly processesSupport installation, qualification, and validation of new equipmentCreate and maintain preventive maintenance procedures as neededPerform or lead feasibility assessments, process development, and time studiesSupport manufacturing with troubleshooting, process improvements, and re-entry-to-line activitiesEscalate complex equipment or process issues to Technology Manager as appropriateValidation, Testing & DocumentationDevelop and/or lead verification and validation activities, including test planning, execution, and reportingPrepare technical documentation to support design control requirements, including:Test protocols and reportsEngineering drawingsDesign history file documentationEnsure compliance with good documentation practices and regulatory requirementsSupport design changes and product updates for existing product linesProject & Technical LeadershipCommunicate project status, risks, technical feasibility, and resource needs to project teams and leadershipSupport or lead project schedules, deliverables, and technical execution depending on levelCollaborate with cross-functional teams including Quality, Manufacturing, Supply Chain, and Project ManagementEngage with senior engineers, principal engineers, and leadership for technical guidance and alignmentLead or support customer complaint investigations and corrective actionsVendor & External CollaborationCollaborate with external vendors on materials, components, tooling, and manufacturing processesSupport or lead supplier technical discussions and development activitiesAssist in quotation and technical input for new product development opportunities (Senior level responsibility)Leadership (Senior Level Emphasis)Lead engineering deliverables and technical execution of projectsMentor and support development of junior engineers and team membersDrive resolution of complex technical challenges with minimal supervisionSupport resource planning, budgeting, and technical input into project planning activitiesContribute to continuous improvement of engineering practices and design standardsEducationBS or MS in Biomedical Engineering, Mechanical Engineering, or related discipline requiredExperienceEngineer II:3+ years of experience in medical device engineering or related fieldSenior Engineer:6+ years of experience in medical device engineering or related fieldSkills & QualificationsStrong experience in medical device design and developmentProficiency in SolidWorks or equivalent CAD softwareHands-on prototyping and lab-based engineering experienceStrong knowledge of materials and manufacturing processes (e.g., thermal bonding, PTFE processing, fixture design, etc.)Experience with validation (IQ/OQ/PQ) and design controlsStrong analytical and problem-solving skillsExcellent verbal and written communication skillsProficiency in Microsoft Office SuiteFamiliarity with hand tools and manufacturing equipmentPhysical RequirementsAbility to work in both laboratory and manufacturing environmentsRegular use of hands, arms, and fingers for engineering and computer workAbility to sit, stand, and move within production and lab environmentsNormal vision and hearing required for documentation and communicationMust be able to effectively communicate in person, electronically, and by phonePerformance ExpectationsAdherence to Aptyx Quality System and SOPsTimely and accurate completion of engineering documentation and deliverablesAbility to clearly communicate project status, risks, and technical challengesQuality and completeness of design outputs and documentationOn-time and on-budget execution of assigned project responsibilitiesDemonstrated proficiency in SolidWorks and engineering drawing standardsUnderstanding and application of the design and development (D&D) processDemonstrated progression in technical depth, autonomy, and leadership based on level