R&D Engineering Manager

Aptyx•Charlotte, NC

17h

About The Position

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.

Requirements

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or related engineering discipline required.
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.
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.
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).

Nice To Haves

Master's degree preferred.
Experience developing Class II and/or Class III medical devices.
Demonstrated experience with catheter-based, minimally invasive, or interventional medical devices strongly preferred.
Experience working directly with customers in a contract development and manufacturing (CDMO) environment preferred.

Responsibilities

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.
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.
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.
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.
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.