Manager, Design Quality Engineering

Manager, Design Quality Engineering - Virtual Incision

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Manager, Design Quality EngineeringEngineering Lincoln, NE

Lincoln, NE

Posted 3 weeks ago

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 Apply for this position All fields are required unless marked optional. Your application goes directly to our hiring team's secure review system.

Are you legally authorized to work in the United States? Yes No Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time. First name Last name Email Phone number Address Position applying for

Associate Design Quality Engineer Director of Quality Engineering Operations and Field Support Specialist Executive Assistant Field Service Engineer Manager, Design Quality Engineering Manufacturing Assembly Technician Mechanical Engineer Primary Manufacturing and Process Engineer Regulatory Affairs Specialist Senior Mechanical Engineer Software Engineer

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This position requires you to be onsite in our Lincoln, Nebraska office. Relocation assistance is not provided. Are you local to Lincoln, or willing to relocate at your own expense?

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Natalie Lewis

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Natalie Lewis2026-10-20 11:01:462026-10-20 11:01:46Manager, Design Quality Engineering

August 25, 2026Virtual Incision Receives FDA 510(k) Clearance for the MIRA Surgical System in Benign Hysterectomy ProceduresJune 18, 2025Virtual Incision Appoints Jim Alecxih as Chief Executive OfficerMarch 18, 2025Virtual Incision Explores NVIDIA Isaac for Healthcare in Surgical RoboticsNovember 25, 2024U.S.-Based Remote Robotic-Assisted Surgery Demonstration Successfully Completed Through Collaborations with Virtual Incision, Sovato, City of Hope, and University of Illinois ChicagoJuly 30, 2024Virtual Incision Announces Successful Completion of the First Hysterectomy Performed with the MIRA Surgical SystemApril 30, 2024Virtual Incision Announces Publication of Data from its U.S. Investigational Device Exemption Study in the Clinical Journal, Diseases of Colon and RectumApril 10, 2024Virtual Incision to Showcase Miniaturized Robotic-Assisted Surgery at SAGES 2024March 18, 2024Virtual Incision's MIRA Surgical System to be Featured Among Elite AI-Enabled Innovations at NVIDIA GTC Open PositionsOctober 21, 2026InClinical and Regulatory Affairs Remote Regulatory Affairs SpecialistOctober 20, 2026InEngineering Lincoln, NE Manager, Design Quality EngineeringOctober 20, 2026InEngineering Lincoln, NE Associate Design Quality EngineerSeptember 11, 2026InEngineering Lincoln, NE Software EngineerSeptember 11, 2026InEngineering Lincoln, NE Senior Mechanical EngineerSeptember 11, 2026InEngineering Lincoln, NE Mechanical Engineer

Disclosure and Important Safety Information

The MIRA Surgical System is intended for prescription use only. Patients should talk to their doctor to decide if surgery with a MIRA Surgical System is right for them. Patients and doctors should review all available information on nonsurgical and surgical options and associated risks in order to make an informed decision. Serious complications may occur in any surgery, including minimally invasive surgery with the MIRA Surgical System, up to and including death. Serious risks include, but are not limited to, injury to tissues and organs, and/or conversion to other surgical techniques which could result in a longer operative time and/or complications. For important safety information, including surgical risks and considerations, please also refer to www.virtualincision.com/safety-information. For the product's indications for use, risks, full cautions, and warnings, please refer to the associated user manual(s). Individual outcomes may depend on a number of factors, including but not limited to patient characteristics, disease characteristics, surgeon, and/or hospital experience.

MIRA Surgical System Precaution Statement

The demonstration of safety and effectiveness for the representative specific procedures was based on evaluation of the MIRA Surgical System as a surgical device and did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient's underlying disease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon.

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Virtual Incision 1501 Old Cheney Rd Lincoln, NE 68512

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