Design Assurance Engineer

Your Job

Phillips Medisize is seeking a Design Assurance Engineer to manage the Design History File and Risk Management File on projects through the Design and Development Process at our Hudson, WI location.

This individual will be expected to apply their knowledge of design control principles and quality engineering techniques to ensure that products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer requirements.

Our Team

Phillips Medisize, a Molex Company is an end-to-end provider of innovation, development, and manufacturing solutions to the pharmaceutical, diagnostics and medical device industries.

What You Will Do


* Lead design assurance representative on medical device, in-vitro diagnostic, and combination product design and development teams from early research and strategy through design transfer


* Draft, coordinate, and maintain Customer owned Design History File (DHF) and deliverables


* Represent Phillips Medisize as the subject matter expert in design control regulations and standards during internal and external customer activities, and audits.


* Work closely with multiple disciplines including Human Factors Engineers, Test Engineers, Project Engineers, Electrical Engineers, Mechanical Engineers, Software Engineers, Manufacturing Engineers, and external customers.


* Participate in writing and maintaining user needs and design input requirements.


* Review and approve plans, protocols, and reports for testing, verification, and validation.


* Develop statistical sampling plans for design and development tasks including design verification and design validation.


* Support test method development and validation efforts with the Test Group including identification of applicable standards and guidance, establishing criteria, and approving results.


* Take responsibility for the Risk Management Process, including integration into the design and development process and management of the Risk Management File.


* Write, edit, and maintain risk management plans/reports, and risk assessments including use of risk analysis tools for Design Risk Assessments (dFMEA), System Risk Assessments (Top-Down Analysis), and Hazard Analysis.


* Support root cause analysis investigations for potential design failures or prospective design changes.

Who You Are (Basic Qualifications)


* 4+ years quality/regulatory experience


* Experience or knowledge of the EU MDR, IVDR, IEC 60601


* Experience in Quality Management System regulations and standards including ISO 13485, 21 CFR 820 (specifically 820.30 for Design Controls), and 21 CFR 210/211


* Demonstrated experience with EN ISO 14971

What Will Put You Ahead


* Bachelor's degree in engineering or technical discipline or equivalent experience


* Experience working at or with contract manufacturing / development organizations


* Combination product, and elect...