Control Design Engineer

Virtue America; United States; On-site; USD 85,000 - 125,000; Full time

Job summary

Virtue America is seeking a Design Controls Engineer to support design control activities, DHF documentation, V&V, and regulatory compliance in a medical device setting. You will collaborate across R&D, QA, Regulatory Affairs, and manufacturing to maintain traceability and ensure FDA and ISO 13485 adherence.

Ideal candidates hold a Bachelor's degree in a related engineering discipline and have 0–2 years' experience with design controls, risk management per ISO 14971, and documentation practices.

Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Biotechnology, or a related field.
• 0-2 years of experience in design controls, quality engineering, design assurance, or medical device engineering.
• Knowledge of FDA design control requirements, ISO 13485, and ISO 14971.
• Experience with DHF documentation, design inputs/outputs, and requirements traceability.
• Understanding of design verification, validation, risk management, and change control.
• Strong technical writing, documentation, analytical, and communication skills.

Responsibilities

• Support design control activities throughout the medical device product lifecycle.
• Prepare, review, and maintain Design History Files (DHF) and design documentation.
• Develop and maintain design inputs, design outputs, and traceability matrices.
• Support design reviews and document design changes in accordance with established procedures.
• Assist with design verification and validation activities, including protocols, testing, and reports.
• Support risk management activities in accordance with ISO 14971.
• Maintain traceability between user needs, design inputs, outputs, verification, and validation evidence.
• Support design change control, engineering changes, and documentation updates.
• Collaborate with R&D, Quality Assurance, Regulatory Affairs, Manufacturing, and Engineering teams.
• Identify documentation gaps and support remediation of design control records.
• Ensure compliance with FDA regulations, ISO 13485, and applicable quality system requirements.
• Support internal audits, regulatory inspections, and design control process improvements.

Skills

Design controls

Documentation

V&V

Regulatory compliance

Technical writing

Communication

Education

Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Biotechnology, or related field

Job description

We are seeking a Design Controls Engineer to support design control activities, design documentation, risk management, and regulatory compliance within a medical device or life sciences environment. The ideal candidate will have experience maintaining Design History Files (DHF), supporting design verification and validation (V&V), and ensuring compliance with FDA requirements and ISO 13485 standards.

Key Responsibilities

• Support design control activities throughout the medical device product lifecycle.
• Prepare, review, and maintain Design History Files (DHF) and design documentation.
• Develop and maintain design inputs, design outputs, and traceability matrices.
• Support design reviews and document design changes in accordance with established procedures.
• Assist with design verification and validation activities, including protocols, testing, and reports.
• Support risk management activities in accordance with ISO 14971.
• Maintain traceability between user needs, design inputs, outputs, verification, and validation evidence.
• Support design change control, engineering changes, and documentation updates.
• Collaborate with R&D, Quality Assurance, Regulatory Affairs, Manufacturing, and Engineering teams.
• Identify documentation gaps and support remediation of design control records.
• Ensure compliance with FDA regulations, ISO 13485, and applicable quality system requirements.
• Support internal audits, regulatory inspections, and design control process improvements.

Required Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Biotechnology, or a related field.
• 0-2 years of experience in design controls, quality engineering, design assurance, or medical device engineering.
• Knowledge of FDA design control requirements, ISO 13485, and ISO 14971.
• Experience with DHF documentation, design inputs/outputs, and requirements traceability.
• Understanding of design verification, validation, risk management, and change control.
• Strong technical writing, documentation, analytical, and communication skills.