Design Quality engineer

Katalyst CRO; Plymouth (MN); On-site; USD 85,000 - 115,000; Full time

Job summary

Katalyst CRO is looking for a candidate with a strong understanding of design controls and risk management for medical devices. This role requires ensuring compliance across the product lifecycle, focusing on ultrasound and imaging systems.

The ideal applicant will have experience in DFMEA, regulatory standards, and systems engineering. Familiarity with requirement management tools such as DOORS or Jama is preferred.

Qualifications

• Strong understanding of design controls and product lifecycle.
• Experience with DFMEA and risk analysis.
• Familiarity with regulatory standards ISO 13485 and ISO 14971.

Responsibilities

• Ensure compliance to design controls throughout the product lifecycle.
• Conduct risk management activities for medical devices.
• Verify and validate design output against input requirements.

Skills

Design controls & product lifecycle

Systems engineering

Tools

DOORS

Jama

Job description

Job Description

Responsible for ensuring compliance to design controls, risk management, and verification/validation activities across the product lifecycle for medical devices, with a strong preference for ultrasound/imaging systems.

Skill Requirements

• Strong understanding of: Design controls & product lifecycle
• Systems engineering

Experience In

• DFMEA / risk analysis
• Requirement management tools (DOORS, Jama, etc.)
• V&V execution and review
• Regulatory & Standards Knowledge

Mandatory

• ISO 13485
• ISO 14971

Preferred

• IEC 60601 (electrical safety)
• IEC 62304 (software lifecycle)
• IEC 62366 (usability)

Ultrasound / Imaging Domain (Preferred)

Strong systems thinking Ability to:

• Identify design gaps early
• Drive risk-based decisions