Design Assurance Engineer

Design Assurance Engineer

Duration: 12 months

Location: Weaver Lakes, MN

Job Summary:

Client seeks an experienced Design Assurance Engineer to support design control and risk management activities within a cardiovascular medical device environment. The role will focus heavily on remediating existing quality documentation while also supporting ongoing product development and lifecycle activities.

Responsibilities:

Review and remediate design control and risk management documentation

Support design inputs/outputs, design verification, and design validation activities

Lead Test Method Validation (TMV) efforts and support test method development

Lead and update FMEAs, hazard analyses, and other risk management documentation

Ensure compliance with ISO 13485, ISO 14971, FDA requirements, and internal quality procedures

Support remediation as well as PDP/NPD activities

Participate in design reviews and other Design Assurance activities

Potentially own or support CAPAs and NCRs

Work autonomously while partnering cross-functionally with Engineering, Quality, Manufacturing, and Regulatory teams

Required:

5+ years of Medical Device Design Quality / Design Assurance experience

Strong Design Controls and Risk Management experience

Design control and/or risk management remediation experience

ISO 13485 and ISO 14971 experience

Test Method Validation and test method development experience

FMEA experience

PDP/NPD experience

Ability to work independently in a highly cross-functional environment

Experience with products such as snares, clips, stents, or similar devices preferred

Desired:

Experience with Nitinol

Experience with Cardiovascular products