Manager, Design Quality Engineering

Virtual Incision; Lincoln (NE); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Disability insurance

Life insurance

401(k)

Flexible working hours

PTO

Job summary

Virtual Incision, a medical technology company in Lincoln, NE, seeks a Manager of Design Quality Engineering to lead design control activities across the R&D lifecycle. You will translate customer needs into testable requirements, ensure traceability, and drive risk management and verification efforts to enable compliant product development.

You will work hands-on with engineering teams, provide practical coaching, and coordinate with Regulatory, Clinical, and Quality teams to support design

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or related field.
• 7+ years in medical device design quality or related engineering discipline.
• 2+ years of people leadership or project leadership experience.
• Experience with medical device design controls and product development from concept to commercialization.
• Strong FDA/ISO knowledge: ISO 13485, ISO 14971, CAPA, change control.

Responsibilities

• Lead the Design Quality Engineering function and serve as the primary design control expert within R&D.
• Work with engineering teams to ensure design control requirements are understood, practical, and consistently executed.
• Provide hands-on review, coaching, and problem solving rather than merely approving processes.
• Translate customer needs into clear, testable design requirements and maintain traceability across design inputs/outputs, risk controls, verification, and validation.
• Own and maintain requirements-management discipline with bidirectional traceability.
• Lead risk management activities per ISO 14971, including DFMEA and use-related risk analysis.
• Oversee product testing, verification, validation strategies, and reports.
• Collaborate with Regulatory Affairs, Clinical, Quality, Supply Chain, and Program Management for submissions and commercialization.
• Support audits and regulatory inspections related to product development and design controls.
• Mentor and develop Design Quality Engineering and testing personnel.

Skills

Design quality

Regulatory knowledge

Requirements management

Leadership

Problem solving

Education

Bachelor's degree in Engineering

Tools

Traceability tools

Verification methods

Job description

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

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 visibleimpact.

Why VirtualIncision

• Work on innovative robotic surgical technology with the potential to improve patientcare.
• 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, andteamwork.
• Competitive benefits including medical, dental, vision, disability and life insurance, 401(k), flexible working hours, andPTO.

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 externalstandards.

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 approvalresource.
• 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, andvalidation.
• Challenge requirements for clarity, completeness, testability, technical rationale, and appropriate linkage to customer needs and productrisk.
• 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 thefact.
• 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 objectiveevidence.
• Lead the product testing function and directly manage the testing team supporting R&Dprograms.
• Partner with R&D leadership and project teams to develop verification and validation strategies that are efficient, risk‑based, and aligned with programobjectives.
• Ensure test methods, protocols, acceptance criteria, test execution, and reports are technically sound, repeatable, appropriately documented, and compliant with applicable standards andprocedures.
• Ensure verification activities demonstrate that design outputs meet design inputs and validation activities demonstrate that the product meets user needs and intendeduses.
• Provide technical leadership in resolving test failures, requirement gaps, design‑control issues, and other development qualityconcerns.
• 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 practicalsolutions.
• 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 designcontrols.
• 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 programexecution.

The Ideal Candidate Will Be AbleTo:

• Operate effectively as both a hands‑on technical contributor and a peopleleader.
• Be viewed by R&D engineers as a practical partner who improves development rigor and execution, not simply as a compliancegatekeeper.
• 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 ofresults.
• Balance speed, innovation, product quality, and regulatory compliance in a fast‑paced development environment.
• Communicate clearly with engineers, project leaders, executive leadership, auditors, and regulatoryagencies.

Qualifications:

Required

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related technicaldiscipline.
• 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 leadershipexperience.
• 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 riskmanagement.
• 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 changecontrol.
• Demonstrated ability to work directly with cross‑functional engineering teams and influence technicaldecisions.
• Strong analytical, problem‑solving, organizational, and communication skills.

Preferred

• Advanced degree in Engineering, Quality, or a related technicalfield.
• ASQ Certified Quality Engineer (CQE) or similar certification.
• Experience with software‑controlled, robotic, electromechanical, or Class II/III medicaldevices.
• 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.

Status: Exempt

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 informeddecision.

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 hospitalexperience.

MIRA Surgical System PrecautionStatement

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 trainedsurgeon.

Contact

Virtual Incision
1501 Old CheneyRd
Lincoln, NE68512