Associate Design Quality Engineer

Virtual Incision; Lincoln (NE); Sur place; USD 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

Disability insurance

Life insurance

401(k)

Flexible working hours

PTO

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Analytical skills

Problem solving

Attention to detail

Communication

Collaboration

MS Office

Formation

Bachelor's degree in Engineering or related field

Description du poste

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 Associate Design Quality Engineer supports product development activities to ensure compliance with design control requirements and quality system procedures throughout the product lifecycle. Working closely with Engineering, Quality, Regulatory Affairs, and other cross-functional partners, this role assists with requirements management, risk management, design control documentation, and verification and validation activities. This position provides an excellent opportunity for an early-career engineer to develop expertise in medical device product development within a regulated environment.

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.

Qualifications:

Required

• Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Systems Engineering, Quality Engineering, Life Sciences, or a related technical 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.

Preferred

• Internship, co‑op, or project experience in medical devices, robotics, healthcare technology, or other regulated industries.
• Familiarity with FDA Quality System Regulations, ISO 13485, and/or ISO 14971.
• Exposure to design controls, risk management, verification, validation, or systems engineering principles.
• Experience with technical documentation or requirements management tools.
• Interest in pursuing a career in medical device quality engineering.

Status: Exempt

Virtual Incision is an Equal Opportunity Employer and values diversity in its workforce.