Senior Medical Device Design Assurance Engineer

Coloplast; Minneapolis (MN); Hybrid; USD 106,000 - 159,000; Full time

Benefits offered by this job

Health and wellness benefits

401(k) with match

Flexible work arrangements

Job summary

Coloplast is seeking an Interventional Urology Senior Design Assurance Engineer to support new product development and commercial products. The role involves leading design reviews, defining design inputs/outputs, and ensuring compliance with design controls and regulatory expectations.

You will collaborate with R&D, conduct risk analyses, support verification/validation, and drive quality-system deliverables to improve efficiency. Travel up to 10% may be required.

Qualifications

• BS in Engineering with Biomedical or Mechanical preferred.
• ASQ Certified Quality Engineer preferred.
• Ability to work independently and with general direction.
• Familiarity with design controls, risk management, statistics, and test method validation.

Responsibilities

• Lead and participate in design reviews for new product development and commercial products.
• Collaborate with R&D to define design inputs/outputs and relationships.
• Apply design standards, create and validate test methods.
• Document risks (Hazard Analysis, DFMEA, PFMEA, UFMEA).
• Support design verification, validation, and usability testing.

Skills

Independent work

Task management

Team leadership

Technical writing

Design controls

Risk management

FDA/QSR/ISO knowledge

Problem solving

Travel readiness

Education

BS in Engineering

ASQ CQE

Job description

Coloplast is seeking an Interventional Urology Senior Design Assurance Engineer to support new product development and commercial products. The role involves leading design reviews, defining design inputs/outputs, and ensuring compliance with design controls and regulatory expectations.

You will collaborate with R&D, conduct risk analyses, support verification/validation, and drive quality-system deliverables to improve efficiency. Travel up to 10% may be required.