Senior R&D Engineer (Class II and Class III Interventional Devices)
hace 17 días
Charlotte
Job Description Position Summary The Senior R&D Engineer is a highly technical individual contributor responsible for leading the design, development, prototyping, testing, and transfer of Class II and Class III interventional medical devices from concept through production. This position serves as a technical leader within the R&D organization, applying advanced engineering knowledge and hands-on expertise to develop complex catheter-based systems and other minimally invasive medical devices. The Senior R&D Engineer will have demonstrated expertise in interventional catheter technologies, ePTFE, stents, catheter-based delivery systems, polymers, extrusion, braiding, bonding, coatings, and related medical device technologies. The position requires the ability to translate customer needs and clinical requirements into manufacturable product designs while working within a regulated medical device environment. The Senior R&D Engineer leads technical development activities, mentors other engineers, provides technical direction on complex projects, and works closely with customers, Program Management, Quality, Manufacturing Engineering, Operations, and external suppliers to successfully deliver products that meet customer, regulatory, quality, cost, and schedule requirements. Essential Duties and Responsibilities Technical Product Development • Lead the development of complex Class II and Class III interventional medical devices, with particular emphasis on catheter-based systems and minimally invasive delivery technologies., • Serve as a technical subject matter expert for catheters, catheter assemblies, delivery systems, stents, ePTFE components, polymers, tubing, shafts, balloons, braiding, bonding, coatings, and related device technologies., • Develop and engineer medical devices from initial concept through design transfer and production launch., • Translate customer requirements, clinical needs, design inputs, and performance requirements into robust product designs., • Lead hands-on product and process development activities, including concept development, design iteration, prototyping, characterization, optimization, and troubleshooting., • Design components and assemblies using SolidWorks and other applicable engineering tools., • Build and evaluate prototypes in a laboratory environment and develop practical solutions to complex technical challenges., • Design, prototype, and construct catheter-based delivery systems and other disposable medical devices supporting applications across areas such as cardiology, peripheral vascular, neurology, structural heart, and urology., • Apply knowledge of materials, mechanical properties, tolerances, interfaces, joining methods, and manufacturing processes to optimize device performance., • Evaluate new materials, components, technologies, and suppliers to improve product performance, manufacturability, reliability, and cost., • Lead technical problem-solving and root-cause investigations for product and process issues. Design Controls, Verification & Validation • Develop and maintain technical documentation required by the Aptyx Quality System and applicable design control processes., • Develop design inputs, outputs, specifications, drawings, risk documentation, design reviews, and other product development documentation., • Develop and execute Design FMEAs, process risk assessments, and other risk management activities., • Develop feasibility, reliability, verification, and validation testing strategies for catheter systems and other medical devices., • Develop and validate appropriate in-vitro test methods, simulated-use models, bench testing, and other performance evaluation methods., • Support or lead verification and validation activities, including protocol development, test execution, data analysis, technical reports, and resolution of test failures., • Analyze test data and engineering results to determine product performance and make data-driven design decisions., • Ensure design activities are completed in accordance with project phase requirements, design control procedures, and applicable regulatory expectations., • Complete required project phase checklists and technical deliverables accurately and on schedule. Project & Technical Leadership • Lead the technical execution of assigned R&D projects, ensuring technical objectives, timelines, budgets, and customer requirements are achieved., • Provide technical leadership and mentorship to R&D Engineers and other technical team members., • Establish development strategies, technical approaches, project milestones, resource requirements, and development plans., • Identify technical risks early and develop mitigation strategies to keep projects moving forward., • Communicate project technical status, risks, issues, and recommendations clearly to customers, Program Management, leadership, and cross-functional teams., • Participate in customer meetings and serve as a technical representative for assigned development projects., • Support the quotation process by providing technical input regarding development approach, materials, equipment, testing, labor, timelines, and project risk., • Collaborate with Program Management to maintain alignment between technical execution, customer expectations, project scope, and schedule., • Provide technical guidance during design reviews and customer interactions. Manufacturing & Design Transfer • Develop products with Design for Manufacturability (DFM) and Design for Assembly principles throughout the development process., • Work closely with Manufacturing Engineering to develop scalable manufacturing processes, equipment, tooling, fixtures, and procedures., • Develop pilot manufacturing equipment, processes, and procedures necessary to support product development and production launch., • Assess process feasibility and provide engineering support for process validation, equipment qualification, capability studies, and time studies., • Lead or support the transition of products from R&D into manufacturing, ensuring technical knowledge and product requirements are effectively transferred., • Engage Manufacturing Engineering early in the development process to ensure designs are manufacturable, scalable, and capable of meeting production requirements., • Support production through the completion of the development and transfer process and provide technical support as needed following launch. Equipment & Laboratory Development • Identify, acquire, install, and qualify new laboratory and development equipment required to support product development., • Develop equipment qualification documentation and PM procedures as necessary., • Support equipment maintenance and troubleshooting within the scope of technical expertise and escalate issues appropriately., • Support or perform equipment re-entry activities following maintenance, modification, or repair., • Maintain a safe, organized, and controlled laboratory environment consistent with applicable company and regulatory requirements. Supplier & External Technical Collaboration • Collaborate with external suppliers and technical partners on the sourcing and development of catheter materials, components, processing technologies, and specialized services., • Evaluate supplier capabilities and technical feasibility of new materials and processes., • Participate in supplier technical reviews, troubleshooting, development activities, and qualification efforts., • Develop technical specifications and acceptance criteria for externally sourced components and processes. Sustaining Engineering & Customer Support • Lead engineering changes and improvements to existing product lines as required., • Investigate and resolve technical issues associated with released products., • Support customer complaints and investigations by providing technical analysis, testing, root-cause evaluation, and corrective action recommendations., • Partner with Quality and Manufacturing to identify opportunities to improve product reliability, manufacturability, cost, and performance., • Apply lessons learned from development and production to future product designs and processes. Quality & Compliance • Follow the Aptyx Quality System and all applicable SOPs identified within the employee's Training Matrix., • Ensure all engineering activities are performed in accordance with applicable FDA, ISO 13485, ISO 14971, and other relevant medical device requirements., • Maintain accurate, complete, and timely engineering documentation., • Participate in internal and external audits as required., • Demonstrate a strong understanding of design controls, risk management, traceability, change control, and documentation requirements within a regulated medical device environment. Required Qualifications • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or a related engineering discipline., • Typically 7+ years of progressive medical device R&D or product development engineering experience, with demonstrated technical depth in interventional or catheter-based medical devices., • Significant hands-on experience developing Class II and/or Class III medical devices., • Strong technical experience with catheter systems and interventional medical devices., • Demonstrated knowledge of ePTFE, polymers, stents, catheter shafts, tubing, braiding, bonding, coatings, delivery systems, and related materials/processes., • Strong understanding of medical device design controls, verification and validation, risk management, and design transfer., • Proficiency with SolidWorks or comparable 3D CAD software., • Demonstrated ability to independently troubleshoot complex product and process issues using structured engineering and root-cause methodologies., • Experience developing and executing engineering test methods and analyzing test data., • Experience working directly with manufacturing, suppliers, customers, and cross-functional technical teams., • Strong technical writing, documentation, communication, and presentation skills. Preferred Qualifications • Advanced experience with interventional cardiology, peripheral vascular, neurovascular, structural heart, or other catheter-based medical technologies., • Direct experience with ePTFE processing and applications., • Experience with stent design, delivery systems, deployment mechanisms, or minimally invasive implantable devices., • Experience with catheter extrusion, tipping, bonding, laser processing, heat forming, reflow, braiding, coating, or related catheter manufacturing technologies., • Experience developing products for Class III implantable or interventional applications., • Experience with design transfer into high-volume or highly regulated medical device manufacturing., • Experience mentoring engineers or serving as a technical lead., • Experience with statistical analysis, DOE, tolerance analysis, design optimization, and engineering modeling., • Experience working directly with medical device customers and clinical stakeholders. Core Competencies • Advanced Technical Expertise – Demonstrates deep technical knowledge of catheter-based medical devices, materials, design, development, and manufacturing processes., • Hands-On Engineering – Willing and able to work directly with prototypes, laboratory equipment, materials, tooling, and manufacturing processes to solve technical problems., • Product Development – Effectively moves complex medical devices from concept through development, verification, validation, and production transfer., • Technical Leadership – Provides technical direction, mentorship, and problem-solving leadership without relying solely on formal authority., • Problem Solving & Root Cause Analysis – Breaks down complex technical problems, identifies root causes, and develops effective, sustainable solutions., • Design for Manufacturability – Incorporates manufacturing capability, process variation, scalability, and cost into product design decisions., • Quality & Regulatory Discipline – Maintains strong adherence to design controls, risk management, documentation, and applicable regulatory requirements., • Customer Focus – Understands customer and clinical requirements and translates them into effective technical solutions., • Cross-Functional Collaboration – Builds strong partnerships across R&D, Quality, Manufacturing Engineering, Operations, Program Management, and suppliers., • Technical Communication – Clearly communicates complex engineering concepts, risks, test results, and recommendations to both technical and non-technical audiences., • Continuous Improvement – Seeks opportunities to improve product performance, processes, reliability, manufacturability, and development efficiency. Physical / Work Environment • Regularly works in a laboratory, engineering, manufacturing, and office environment., • May be required to handle small components, prototypes, laboratory equipment, tooling, and manufacturing materials., • Ability to work safely with laboratory and manufacturing equipment and follow applicable PPE and safety requirements., • Occasional travel may be required to support customers, suppliers, or other Aptyx locations. Acknowledgement I have received a copy of this job description, have read and understood it, and will complete all assigned duties and responsibilities. I recognize that the company reserves the right to modify this job description and that I will be informed of any and all modifications prior to their effective date.
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