R&D Engineering Manager
Listed on 2026-07-06
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Engineering
Product Engineer, Quality Engineering, Engineering Design & Technologists, Biomedical Engineer
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.
- 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…
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