Design Quality Engineer: Medical Devices – Controls & Risk

Intellectt Inc; Minnesota; On-site; USD 83,000 - 152,000; Part time

Job summary

Intellectt Inc is seeking an experienced Design Quality Engineer to support design quality activities for cardiovascular medical devices, with a focus on design controls remediation and regulatory compliance.

The ideal candidate has ~5 years in Design Quality, Quality Engineering, and TMV/DV within the medical device industry, plus strong technical writing and cross-functional collaboration across R&D, Regulatory, and Manufacturing.

Qualifications

• Approximately 5 years of experience in the medical device industry.
• Experience in Design Quality, Quality Engineering, or a closely related function.
• Strong hands-on experience with design controls and design control remediation.
• Experience with DFMEA, hazard analysis, and product risk management.
• Experience reviewing and developing design outputs.
• Experience with Design Verification (DV) and Design Validation/Technical Medical Verification (TMV).
• Experience maintaining and updating risk management files.
• Ability to independently review technical documentation, identify gaps, and develop remediation plans.

Responsibilities

• Review quality engineering documentation and identify gaps related to design control and regulatory requirements.
• Lead and execute design control remediation activities, including documentation updates and closure of identified gaps.
• Develop, review, and maintain DFMEA documentation.
• Perform hazard analysis and product risk assessments.
• Review design outputs to ensure alignment with inputs and requirements.
• Support and lead DV and TMV activities.
• Maintain product risk management files and risk controls documentation.
• Collaborate with R&D, Quality, Regulatory, Manufacturing and other cross-functional teams to resolve design control issues.

Skills

Design controls

Quality engineering

DFMEA

Hazard analysis

Risk management

Design Verification

TMV

Technical writing

Cross-functional collaboration

Regulatory compliance

Education

Bachelor’s degree in Engineering,Biomedical Engineering, Mechanical Engineering, or related technical discipline

Job description

Intellectt Inc is seeking an experienced Design Quality Engineer to support design quality activities for cardiovascular medical devices, with a focus on design controls remediation and regulatory compliance.

The ideal candidate has ~5 years in Design Quality, Quality Engineering, and TMV/DV within the medical device industry, plus strong technical writing and cross-functional collaboration across R&D, Regulatory, and Manufacturing.