Design Quality Engineering Manager — Flexible Hours

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

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