Sr. Design Assurance Engineer

Medtronic; Mounds View (MN); Hybrid; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Sr. Design Assurance Engineer to play a crucial role in developing and conducting technical reliability studies for innovative medical devices. This position offers the opportunity to ensure compliance with rigorous industry standards while supporting the qualification of critical components. You will be at the forefront of risk management and design assurance, working collaboratively in a hybrid model that promotes flexibility. Join a team dedicated to enhancing patient outcomes through cutting-edge technology and quality assurance practices. If you are passionate about making a difference in the medical field and thrive in a dynamic environment, this role is perfect for you.

Qualifications

• Experience in conducting technical reliability studies for medical devices.
• Strong knowledge of FDA QSR and ISO standards.

Responsibilities

• Develop and conduct reliability studies for medical device components.
• Ensure compliance with industry regulations and specifications.

Skills

Technical Reliability Studies

Design Assurance

Risk Management

Process Improvement Tools

Regulatory Compliance

Education

Bachelor's Degree in Engineering

Master's Degree (preferred)

Tools

DMAIC

Root Cause Analysis

5 Whys

Fishbone Diagram

Job description

We anticipate the application window for this opening will close on - 1 Jul 2025.

Position Description:

Sr. Design Assurance Engineer at Medtronic, Inc., located in Mounds View, MN. Responsible for developing, coordinating, and conducting technical reliability studies supporting manufacturing operations, evaluating compliance of materials and processes with specifications and customer requirements. Support qualification of Coronary & Renal Denervation (CRDN) medical device components, ensuring all finished goods and processes meet specifications. Provide Design Assurance support to various Operating Unit (OU) Sustaining & product Surveillance initiatives. Conduct evaluations of engineering design concepts and design of experiments (DOE). Support product design verification and validation. Coordinate Reliability Engineering for Class II and III Medical Devices. Navigate industry and government regulations, including FDA QSR 21 CFR 820, ISO 13485, EU MDR, ISO 14971, SOTA, and GMP. Responsible for risk management activities by maintaining product risk documentation. Evaluate non-conformances, complaints, and CAPA. Leverage process improvement tools such as DMAIC, Root Cause Analysis, 5 Whys, Fishbone, and cause mapping. The position permits a hybrid model, requiring 2-3 days per week on site.