Design Assurance Engineer III

Integer•Plymouth, MN

2d•Onsite

About The Position

Lake Region Medical, Inc. dba Integer Holdings Corporation seeks a Design Assurance Engineer III in Plymouth, MN. This role actively participates in development project teams, performing quality/reliability engineering activities to ensure design/development procedures, design controls, supplier controls, and test requirements are fulfilled. The engineer will lead Risk Management (ISO 14971) activities, potentially leading cross-functional teams in planning, analyses (DFMEA, FTA, Risk/Benefit), and mitigations. They will maintain the risk management file for the life of the device, generate and review project deliverables such as design verification and validation protocols and reports, and process validation protocols and reports. The role involves coordinating with R&D on technical documentation, working with Product Development Manufacturing Engineering on test fixtures, production acceptance criteria, and test methodology, and coordinating sourced item qualification activities and supporting supplier risk management initiatives. Additionally, the engineer will conduct independent reviews of DHF and Technical files, provide technical standards interpretation, determine appropriate statistical methods, and support root cause analyses, CAPA preparation, and Distributed Product Risk Assessment. The position also requires drafting and updating SOPs as needed.

Requirements

Bachelor’s degree in Mechanical Engineering or related field plus 5 years’ experience OR Master’s degree in Mechanical Engineering or a related field plus 3 years' of experience.
5 years of experience (or 3 years with Master’s) in the following: Use of Quality lean sigma tools (Root Cause Analysis, QFD, Ishikawa, Kepner Tregoe); Performing Gage Repeatability and Reliability studies and Attribute Agreement Analysis for test method validation; performing sourced item qualification (sourced component and supplier qualification); and investigating non-conforming material, review and dispositions including review of schematics, drawings and design specifications.
4 years of experience (or 2 years with Master’s) in the following: Creating risk management files per ISO 14971 for Class 2 or 3 devices for EU Medical Device Regulation (EU MDR 2017) or 510K FDA submissions; and Performing Design Verification and Validation (creating protocols, executing testing and creating reports) for Class 2 or 3 devices for EU Medical Device Regulation (EU MDR 2017) or 510K FDA submissions.
Must also have authority to work permanently in the U.S.

Responsibilities

Adheres to Integer values and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
Actively participates in development project teams.
Performs quality/reliability engineering activities to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled.
Builds consensus where appropriate.
Leads Risk Management (ISO 14971) activities.
May lead cross functional teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations.
Maintains risk management file for the life of the device.
Generates and/or reviews related project deliverables such as: design verification and design validation protocols and reports as well as process validation protocols and reports.
Coordinates with R&D in the review of technical documentation.
Works with Product Development Manufacturing Engineering in the development of test fixtures, develop production acceptance criteria and test methodology.
Coordinates sourced item qualification activities and supports supplier risk management initiatives.
Conducts Independent review of DHF and Technical files, provides technical standards interpretation, and determines appropriate statistical methods, including sample size determination.
Provides support in conducting root cause analyses, preparation of CAPA and Distributed Product Risk Assessment.
Draft and update SOPs as required.