Design Quality Engineer

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

Title: Design Quality Engineer – Design Controls & Risk Management

Employment Type: Contract 6+ Months

Industry: Medical Devices / Cardiovascular

Position Overview:

We are seeking an experienced Design Quality Engineer to support design quality activities, design control remediation, and quality engineering initiatives for cardiovascular medical device products.

The ideal candidate will have approximately 5 years of experience in Design Quality, Quality Engineering, Technical Medical Verification (TMV), design controls, risk management, and Design Verification/Validation within the medical device industry.

This role will focus heavily on reviewing Quality Engineering documentation, identifying gaps against design control requirements, executing remediation activities, and maintaining product risk management documentation. Experience with nitinol-based technologies and cardiovascular medical devices is highly desirable.

Key Responsibilities:

• Review existing 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 Design Failure Mode and Effects Analysis (DFMEA) documentation.
• Perform and support hazard analysis and product risk assessments.
• Review and develop design outputs to ensure alignment with design inputs and applicable requirements.
• Support and lead Design Verification (DV) and Design Validation / Technical Medical Verification (TMV) activities.
• Lead updates and maintenance of product risk management files.
• Document identified risks, risk mitigations, and verification of risk controls.
• Ensure design documentation is complete, traceable, accurate, and compliant with applicable quality and regulatory requirements.
• Review technical documentation and develop appropriate remediation plans for identified gaps.
• Collaborate with R&D, Quality, Regulatory, Manufacturing, and other cross-functional teams to resolve design control and documentation issues.
• Provide technical leadership for design quality activities and remediation projects.
• Support implementation of sustainable improvements to design control and quality processes.
• Apply applicable medical device standards and regulatory requirements to design quality activities.
• Support design quality activities across various medical device technologies throughout the product lifecycle.

Required Qualifications:

• Bachelor’s degree in Engineering, Biomedical Engineering, Mechanical Engineering, or a related technical discipline.
• 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).
• Experience with 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.
• Experience working within regulated medical device product development environments.
• Strong technical writing and documentation skills.
• Strong cross-functional communication and collaboration skills.

Preferred Qualifications:

• Experience with cardiovascular medical devices.
• Experience with nitinol-based medical device technologies.
• Familiarity with applicable ISO and medical device quality standards.
• Experience working closely with R&D, Regulatory, Manufacturing, and Quality organizations.
• Experience supporting products through multiple stages of the medical device lifecycle.