At Tactile Medical, we specialize in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency and respiratory illnesses. At Tactile Medical, we specialize in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency and respiratory illnesses. The Principal Design Assurance Engineer serves as the technical leader for Design Assurance across the product lifecycle.

Requirements

, and leading best practices in design controls, risk management, and design verification and validation. The Principal Engineer provides technical mentorship, influences organizational quality strategy, and partners with cross-functional leadership to ensure the development of safe, effective, and compliant medical devices.

Responsibilities

Serve as the Design Assurance subject matter expert for New Product Introduction programs Establish Design Assurance strategies, quality plans, and risk-based approaches for product development and lifecycle management Provide technical leadership and influence decisions across Engineering, Program Management, Operations, Marketing, and Regulatory Affairs Own quality system processes for Design Control, Risk Management, and Product Development processes Lead design assurance activities throughout the product lifecycle from concept through commercialization, sustaining engineering, and product retirement.

Qualifications

Required: Bachelor’s degree in Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Materials Science, or related technical discipline required 10+ years of experience in quality engineering, design assurance, or product development within the medical device industry Demonstrated success leading quality strategy for complex medical device development programs through commercialization Preferred: ASQ certification such as Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), Certified Six Sigma Black Belt (CSSBB), or equivalent quality certification Experience serving as a design assurance or quality lead for electromechanical, software-enabled, or connected medical device products Prior experience mentoring engineers, leading quality capability-building initiatives, or influencing quality strategy across a matrixed organization Knowledge Skills Expert knowledge of Design Controls, Risk Management, and Product Realization for medical devices Expert understanding of FDA Quality System Regulation, ISO 13485, ISO 14971, IEC 62304, IEC 60601, and related standards Advanced knowledge of statistical methods, reliability engineering, validation methodologies, and data analytics Demonstrated ability to lead through influence without direct authority. Strong business acumen with the ability to balance risk, compliance, and business objectives Exceptional communication, facilitation, and executive presentation skills. Demonstrated ability to lead multiple highly complex technical initiatives simultaneously.

Proven mentoring and leadership capabilities.