Associate Principal R&D Engineer
On-siteConcord, North Carolina, United States
Job Summary
Own the UCC pump and fluid platform capability roadmap across evacuation, battery/power, interfaces, and detection systems. Define "crawl/walk/run" maturity steps for each domain and align them to product release trains. Lead periodic strategy reviews to publish roadmaps with clear deliverables, decision points, and success metrics. Establish system-level architecture principles, modularity strategy, and interface expectations to ensure improvements are reusable across multiple products. Serve as technical authority for architecture choices, including pump mechanisms, motor control, fluid paths, and sensing strategies. Partner with engineering, quality, regulatory, operations, and supply chain teams to align platform choices with manufacturability, yield, cost, and reliability. Translate the roadmap for product design teams and promote adoption of platform modules, standards, and common design patterns. Use field data, complaints, and service returns to prioritize next platform improvements.
Required Qualifications
- BS/MS in Mechanical Engineering, Electrical Engineering, Systems Engineering, Biomedical Engineering, or related technical discipline
- 10+ years of experience in electromechanical medical devices, portable pump systems, fluid management systems, regulated product development, or platform-based product development with reuse across releases
- Demonstrated success leading cross-functional technical strategy, not only subsystem design or program execution
- Strong background in systems thinking, platform architecture, trade studies, risk management, design controls, verification strategy, reliability engineering, and supplier/technology evaluation
- Ability to influence without direct authority across systems, mechanical, electrical, software, quality, regulatory, marketing, operations, human factors, service, supply chain, and program teams
- Minimum of 4 days of in-office presence per week
- Proof that you are fully vaccinated against COVID-19
Desired Qualifications
- Experience with portable pumps/fluid management, battery-powered consumer or clinical devices, vacuum/pressure/flow systems, sensors in wet/dirty environments, acoustics/odor control, and consumables ecosystems
- Experience with pump mechanism selection, motor/control strategy, power management, battery/charging systems, liquid level sensing, occlusion detection, leak detection, fault detection, alarm behavior, and nuisance alarm reduction
- Experience with FDA-regulated medical devices, design controls, risk management, verification and validation, usability/human factors, complaint trending, sustaining engineering, and regulated product release processes
- Experience establishing platform governance, architecture review boards, capability scorecards, reusable modules, interface standards, reference architectures, and technology roadmaps across multiple product releases
- Experience with manufacturing scale-up, supplier strategy, component technology evaluation, reliability engineering, serviceability, cost reduction, and lifecycle management for electromechanical platforms
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