Manager, Design Quality Engineering

Job Title:               Manager, Design Quality Engineering                             Date:                      October 19, 2026

Department:        Engineering                                                                           Location:               Onsite, Lincoln, NE

Virtual Incision is advancing robotic-assisted surgery with a focus on expanding access to minimally invasive care. We are a growing medical technology company where experienced leaders have the opportunity to make a meaningful and visible impact.

Why Virtual Incision

• Work on innovative robotic surgical technology with the potential to improve patient care.
• Join an experienced, collaborative team focused on clinical excellence and disciplined execution.
• Take meaningful ownership of products and programs in a hands-on environment.
• Work in a culture that values technical rigor, practical problem-solving, and teamwork.
• Competitive benefits including medical, dental, vision, disability and life insurance, 401(k), flexible working hours, and PTO.

Job Summary:

The Manager, Design Quality Engineering reports to the Vice President of R&D and is responsible for ensuring that product development activities are executed in compliance with design control requirements while enabling efficient, high-quality engineering execution. This is a hands-on leadership role for an experienced Design Quality Engineer who will work directly with R&D teams, contribute to the work, and provide practical guidance throughout the product development lifecycle.

A central responsibility of this role is ensuring that customer and user needs are translated into clear, testable product and system requirements and that traceability is maintained from customer needs through design inputs, design outputs, risk controls, verification, and validation. The Manager will closely work with teams responsible for verification and validation activities and ensure compliance to internal operating procedures as well as external standards. 

Responsibilities:

• Lead the Design Quality Engineering function and serve as the primary design control expert within R&D.
• Work directly alongside engineering teams to ensure design control requirements are understood, practical, and consistently executed throughout development.
• Provide hands-on review, coaching, and problem solving rather than functioning solely as a process or approval resource.
• Ensure customer and user needs are clearly defined and translated into appropriate product, system, subsystem, software, mechanical, and electrical design requirements.
• Own and maintain requirements-management discipline, including clear bidirectional traceability from customer and user needs through design inputs, outputs, risk controls, verification, and validation.
• Challenge requirements for clarity, completeness, testability, technical rationale, and appropriate linkage to customer needs and product risk.
• Ensure effective execution of design planning, design inputs, design outputs, design reviews, verification, validation, design transfer, and design changes in accordance with the company QMS and applicable regulatory requirements.
• Participate actively in design reviews and technical discussions, identifying compliance or quality risks early enough to influence the design rather than documenting issues after the fact.
• Lead design quality planning for new product development and sustaining engineering programs.
• Lead and continuously improve risk management activities in accordance with ISO 14971 and company procedures, including hazard analyses, risk assessments, risk controls, DFMEA, use-related risk analysis, and risk management documentation.
• Ensure risk controls are appropriately translated into design requirements and verified or validated through objective evidence.
• Lead the product testing function and directly manage the testing team supporting R&D programs.
• Partner with R&D leadership and project teams to develop verification and validation strategies that are efficient, risk-based, and aligned with program objectives.
• Ensure test methods, protocols, acceptance criteria, test execution, and reports are technically sound, repeatable, appropriately documented, and compliant with applicable standards and procedures.
• Ensure verification activities demonstrate that design outputs meet design inputs and validation activities demonstrate that the product meets user needs and intended uses.
• Provide technical leadership in resolving test failures, requirement gaps, design-control issues, and other development quality concerns.
• Review and approve key product development documentation and design control deliverables as appropriate.
• Provide independent assessments of development readiness while remaining closely integrated with the R&D team and focused on practical solutions.
• Partner closely with Regulatory Affairs, Clinical, Operations, Quality, Supply Chain, and Program Management to support product development, design transfer, regulatory submissions, and commercialization.
• Support internal and external audits, regulatory inspections, and assessments related to product development and design controls.
• Develop and maintain right-sized design quality procedures, tools, templates, metrics, and working practices that improve both compliance and development effectiveness.
• Lead, mentor, and develop Design Quality Engineering and testing personnel, establishing clear expectations and accountability while remaining actively engaged in day-to-day program execution.

The Ideal Candidate Will Be Able To:

• Operate effectively as both a hands-on technical contributor and a people leader.
• Be viewed by R&D engineers as a practical partner who improves development rigor and execution, not simply as a compliance gatekeeper.
• Take complex customer and user needs and help teams translate them into clear, testable, traceable engineering requirements.
• Recognize design-control and product risks early and work with the team to resolve them without creating unnecessary bureaucracy.
• Apply strong technical judgment to verification and validation planning, test strategy, acceptance criteria, and interpretation of results.
• Balance speed, innovation, product quality, and regulatory compliance in a fast-paced development environment.
• Communicate clearly with engineers, project leaders, executive leadership, auditors, and regulatory agencies.

Qualifications:

Required

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline.
• 7+ years of experience in medical device design quality, product development quality, systems engineering, or a closely related engineering discipline.
• 2+ years of people leadership, technical leadership, or project leadership experience.
• Demonstrated expertise in medical device design controls and direct experience supporting product development from concept through commercialization.
• Strong experience with requirements management, requirements traceability, verification, validation, and risk management.
• Experience developing or reviewing test strategies, protocols, acceptance criteria, test methods, and reports.
• Strong working knowledge of FDA medical device quality requirements, ISO 13485, ISO 14971, design controls, CAPA, and change control.
• Demonstrated ability to work directly with cross-functional engineering teams and influence technical decisions.
• Strong analytical, problem-solving, organizational, and communication skills.

Preferred

• Advanced degree in Engineering, Quality, or a related technical field.
• ASQ Certified Quality Engineer (CQE) or similar certification.
• Experience with software-controlled, robotic, electromechanical, or Class II/III medical devices.
• Experience leading or directly managing an engineering test or verification group.
• Experience with formal requirements-management and traceability tools.
• Experience supporting regulatory submissions and agency interactions.
• Working knowledge of human factors/usability engineering and design assurance methodologies.

Salary:  DOE

Status:  Exempt