Design Assurance Engineer

KOCH INDUSTRIES INC • Hudson, WI • 4h ago

JOB REQUIREMENTS: 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 /... For full info follow application link.
Equal Opportunity Employer, including disability and protected veteran
status. *** APPLICATION INSTRUCTIONS: Apply Online:
ipc.us/t/4C5F5951DF1B4EDA

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