R&D Engineering Manager

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

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