R&D Engineering Manager
19 days ago
Charlotte
Job Description Position Summary The R&D Engineering Manager provides technical and people leadership for the Research & Development Engineering team supporting the design, development, and commercialization of innovative Class II and Class III interventional medical devices. This role is responsible for building and developing a high-performing engineering organization while driving execution of customer development programs from concept through successful transfer into manufacturing. The R&D Engineering Manager serves as the technical leader for multiple customer programs, partnering with cross-functional teams including Quality, Regulatory, Manufacturing Engineering, Operations, Program Management, and Commercial teams to deliver innovative, manufacturable, and compliant medical device solutions. This leader champions engineering excellence, fosters a culture of collaboration and continuous improvement, and ensures compliance with Design Controls, FDA regulations, and ISO 13485 requirements. The ideal candidate is an experienced engineering leader with a strong background in catheter-based and minimally invasive medical devices, exceptional technical problem-solving skills, and a demonstrated ability to coach and develop engineering talent. Core Job Functions Engineering Leadership • Lead, mentor, and develop a team of entry- to mid-level R&D Engineers through coaching, technical guidance, performance management, and career development., • Build a high-performing engineering organization that promotes accountability, collaboration, innovation, and continuous learning., • Establish engineering priorities, allocate resources, and balance workloads across multiple customer development programs., • Recruit, develop, and retain top engineering talent while building succession within the organization., • Foster a culture of ownership, technical excellence, and customer responsiveness. New Product Development • Lead the development of Class II and Class III interventional medical devices from concept through commercialization., • Provide technical leadership for product architecture, design optimization, material selection, and engineering decision-making., • Ensure all development activities comply with Design Control requirements and established product development processes., • Oversee engineering documentation including Design Inputs, Design Outputs, Design Reviews, Design Verification, Design Validation, Design History Files (DHF), and Risk Management files., • Drive Design for Manufacturability (DFM), Design for Assembly (DFA), and Design for Excellence (DFX) throughout product development., • Guide technical problem solving using sound engineering principles, root cause analysis, and data-driven decision making. Design Transfer & Manufacturing Readiness • Lead successful transfer of new products from R&D into manufacturing while ensuring robust, scalable production processes., • Partner with Manufacturing Engineering to develop production-ready processes, fixtures, tooling, and equipment., • Support engineering builds, pilot production, process validation, and manufacturing qualifications., • Collaborate with Operations to ensure designs meet quality, cost, delivery, and manufacturability objectives., • Drive continuous improvement throughout the product lifecycle. Customer & Technical Leadership • Serve as the primary technical leader during customer development programs., • Build trusted customer relationships through technical expertise and responsive communication., • Participate in customer design reviews, engineering meetings, and technical presentations., • Evaluate technical risks and develop mitigation strategies throughout development., • Provide engineering recommendations that balance customer requirements, manufacturability, quality, and regulatory compliance. Quality & Regulatory Excellence • Ensure engineering activities comply with FDA Quality System Regulations, ISO 13485, ISO 14971, and applicable regulatory requirements., • Support CAPAs, Nonconformance investigations, Root Cause Analysis, complaint investigations, and continuous improvement initiatives., • Participate in customer, internal, and regulatory audits as the engineering subject matter expert., • Promote adherence to Good Documentation Practices (GDP) and engineering documentation standards. Leadership Competencies Technical Leadership • Demonstrates expert knowledge of interventional medical device development and engineering best practices., • Makes sound technical decisions that balance innovation, quality, manufacturability, cost, and customer expectations., • Serves as the technical mentor for engineering staff while promoting engineering excellence. People Leadership • Builds trust through coaching, transparency, and accountability., • Develops engineers through mentoring, performance feedback, and growth opportunities., • Creates an engaged, collaborative, and high-performing engineering culture. Execution & Results • Successfully manages multiple development programs while maintaining quality, timelines, and customer expectations., • Anticipates risks and removes barriers to project success., • Delivers commitments through disciplined planning and execution. Strategic Thinking • Aligns engineering priorities with business objectives and customer needs., • Identifies opportunities to improve engineering processes, technologies, and organizational capability., • Drives innovation while maintaining operational discipline. Customer Focus • Builds strong customer partnerships based on technical credibility and responsiveness., • Understands customer applications and translates requirements into practical engineering solutions., • Consistently delivers high-quality engineering support that strengthens customer confidence. Collaboration & Influence • Builds productive partnerships across Engineering, Manufacturing, Quality, Regulatory, Operations, Supply Chain, and Commercial teams., • Influences decisions through technical expertise, collaboration, and effective communication., • Encourages knowledge sharing and teamwork across the organization. Continuous Improvement • Champions Lean thinking and continuous improvement throughout product development., • Identifies opportunities to improve engineering efficiency, quality, and development processes., • Encourages innovation while standardizing best practices across the engineering organization. Problem Solving & Decision Making • Applies analytical thinking and engineering principles to solve complex technical challenges., • Uses structured methodologies including FMEA, Design Reviews, Root Cause Analysis, and risk-based decision making., • Makes timely, data-driven decisions in fast-paced development environments. Minimum Qualifications Education • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or related engineering discipline required., • Master's degree preferred. Experience • 5+ years of progressive engineering experience in medical device product development., • 2+ years of engineering leadership, supervisory, or technical lead experience., • Experience developing Class II and/or Class III medical devices., • Demonstrated experience with catheter-based, minimally invasive, or interventional medical devices strongly preferred., • Proven experience leading new product development from concept through commercialization and design transfer into manufacturing., • Strong working knowledge of FDA Design Controls, ISO 13485, ISO 14971, verification and validation, and risk management., • Experience working directly with customers in a contract development and manufacturing (CDMO) environment preferred. Technical Competencies • Design Controls, • Product Development Lifecycle, • Design Transfer, • Engineering Change Management, • Manufacturing Process Development, • Verification & Validation, • Risk Management (ISO 14971), • DFMEA / PFMEA, • GD&T, • Root Cause Analysis, • CAPA, • Statistical Analysis, • Lean Manufacturing, • Continuous Improvement, • Technical Documentation, • Customer Collaboration, • Medical Device Regulations (FDA & ISO 13485) 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. Employee Signature Date