Medical Device Design Quality Engineer – Risk & V&V

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

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