Medical Device Design Assurance Engineer – Hybrid

Intellectt Inc; Minnesota; Hybrid; USD 90,000 - 120,000; Full time

Job summary

Intellectt Inc. is seeking a Design Assurance Engineer in Minnesota with hybrid work arrangement (3 days onsite).

You will support design control and risk management activities within a cardiovascular medical device environment, focusing on remediation of existing quality documentation and ongoing product development. Key responsibilities include leading TMV, developing FMEAs and hazard analyses, and ensuring compliance with ISO 13485, ISO 14971, and FDA requirements.

Qualifications

• 5+ years of Medical Device Design Quality / Design Assurance experience.
• Experience with ISO 13485, ISO 14971, FMEA, and TMV.
• Remediation of design control and risk management documentation.

Responsibilities

• Review and remediate design control and risk management documentation.
• Lead Test Method Validation (TMV) and support test method development.
• Develop and update FMEAs, hazard analyses, and risk management documentation.
• Ensure compliance with ISO 13485, ISO 14971, FDA requirements, and internal quality procedures.
• Support design verification, validation, design reviews, and PDP/NPD activities.
• Own or support CAPAs and NCRs as needed.

Skills

Design controls

Risk management

ISO 13485

FMEA

FDA requirements

Job description

Intellectt Inc. is seeking a Design Assurance Engineer in Minnesota with hybrid work arrangement (3 days onsite).

You will support design control and risk management activities within a cardiovascular medical device environment, focusing on remediation of existing quality documentation and ongoing product development. Key responsibilities include leading TMV, developing FMEAs and hazard analyses, and ensuring compliance with ISO 13485, ISO 14971, and FDA requirements.