Junior Design Quality Engineer, MedTech — Flexible Hours

Virtual Incision; Lincoln (NE); On-site; USD 65,000 - 90,000; 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 is seeking an Associate Design Quality Engineer to support design control activities across the product lifecycle in a regulated medical device environment. You will work with Engineering, Quality, Regulatory Affairs, and cross-functional partners on requirements management, risk, design history file documentation, and verification/validation.

This early-career role offers hands-on exposure to medical device quality engineering, FDA/ISO compliance, and continuous improvement

Qualifications

• Bachelor's degree in Engineering or related field.
• 0-3 years of engineering, quality, medical device, or related experience.
• Strong analytical and problem-solving skills.
• Excellent attention to detail and organizational skills.
• Strong written and verbal communication skills.
• Ability to work effectively in a collaborative team environment.
• Proficiency with Microsoft Office applications.

Responsibilities

• Support design control activities throughout the product development lifecycle.
• Assist in the development and maintenance of Design History File (DHF) documentation.
• Help maintain traceability between customer needs, design inputs, design outputs, risk controls, verification, and validation activities.
• Participate in design reviews and cross-functional product development meetings.
• Support risk management activities, including hazard analyses, risk assessments, and risk management documentation.
• Assist in creating and maintaining requirements traceability matrices.
• Support verification and validation planning, execution, and documentation activities.
• Review engineering documentation, test protocols, and reports for completeness and compliance.
• Assist with investigations of design-related issues, test failures, and product development concerns.
• Collaborate with Engineering, Clinical, Regulatory, Operations, and Quality teams to support development programs.
• Maintain accurate and organized quality records and documentation.
• Support internal and external audits related to product development and design controls.
• Participate in continuous improvement initiatives that enhance product quality and development effectiveness.
• Develop working knowledge of FDA regulations, ISO standards, and company quality procedures.

Skills

Analytical skills

Problem solving

Attention to detail

Communication

Collaboration

MS Office

Education

Bachelor's degree in Engineering or related field

Job description

Virtual Incision is seeking an Associate Design Quality Engineer to support design control activities across the product lifecycle in a regulated medical device environment. You will work with Engineering, Quality, Regulatory Affairs, and cross-functional partners on requirements management, risk, design history file documentation, and verification/validation.

This early-career role offers hands-on exposure to medical device quality engineering, FDA/ISO compliance, and continuous improvement