Position SummaryThe 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 FunctionsEngineering 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 CompetenciesTechnical 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 QualificationsEducation- 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)
AcknowledgementI 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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