Design Quality engineer

Katalyst CRO; Plymouth (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO in Minnesota seeks a Regulatory/Design Controls Engineer to ensure compliance across the medical device lifecycle, with emphasis on ultrasound/imaging domains. You will drive design controls, risk analysis, V&V efforts, and regulatory alignment to ISO 13485 and 14971 while collaborating with cross-functional teams.

Ideal candidates have strong systems thinking, experience with DFMEA, and proficiency in requirement management tools, such as DOORS or Jama, to support risk-based

Qualifications

• Strong understanding of design controls and the product lifecycle.
• Strong systems engineering background.
• Experience with DFMEA / risk analysis.
• Experience with requirements management tools (DOORS, Jama, etc.).
• V&V execution and review experience.
• Regulatory standards knowledge (ISO 13485, ISO 14971).
• Familiarity with IEC 60601/62304/62366 is a plus.

Skills

Design controls

Product lifecycle

Systems engineering

Regulatory knowledge

FMEA & risk analysis

V&V testing

Requirements management

Tools

DOORS

Jama

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 Requirement

• 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