Koch Business Solutions, LP
Design Assurance Engineer
Koch Business Solutions, LP, Hudson, Wisconsin, United States, 54016
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 electromechanical device work experience ASQ or RAPS certification (CQE, RAC, etc) Strong interpersonal, communication (verbal and written), organizational and project management skills Previous experience with SAP Previous experience with Microsoft Teams This position does not qualify for VISA Sponsorship In order to comply with U.S. export control laws and regulations, this position requires applicants to either provide proof of U.S. citizenship or lawful permanent resident status or be eligible to receive an export authorization (a license) under the International Traffic in Arms Regulations and/or the Export Administration Regulations. Hiring Philosophy
All Koch companies value diversity of thought, perspectives, aptitudes, experiences, and backgrounds. We are Military Ready and Second Chance employers. Learn more about our hiring philosophy here. Who We Are
As a Molex company, Phillips Medisize mobilizes and deploys specialized capabilities and services across highly regulated industries, including health care, regulated consumer, automotive and defense. We design, develop and create innovative and life-changing medical technologies for millions of people around the globe. Our Benefits
Our goal is for each employee, and their families, to live fulfilling and healthy lives. We provide essential resources and support to build and maintain physical, financial, and emotional strength - focusing on overall wellbeing so you can focus on what matters most. Our benefits plan includes - medical, dental, vision, flexible spending and health savings accounts, life insurance, ADD, disability, retirement, paid vacation/time off, educational assistance, and may also include infertility assistance, paid parental leave and adoption assistance. Specific eligibility criteria is set by the applicable Summary Plan Description, policy or guideline and benefits may vary by geographic region. If you have questions on what benefits apply to you, please speak to your recruiter. Equal Opportunities Equal Opportunity Employer, including disability and protected veteran status. Except where prohibited by state law, all offers of employment are conditioned upon successfully passing a drug test. This employer uses E-Verify. Please visit the following website for additional information: http://www.kochcareers.com/doc/Everify.pdf #LI-SD5
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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 electromechanical device work experience ASQ or RAPS certification (CQE, RAC, etc) Strong interpersonal, communication (verbal and written), organizational and project management skills Previous experience with SAP Previous experience with Microsoft Teams This position does not qualify for VISA Sponsorship In order to comply with U.S. export control laws and regulations, this position requires applicants to either provide proof of U.S. citizenship or lawful permanent resident status or be eligible to receive an export authorization (a license) under the International Traffic in Arms Regulations and/or the Export Administration Regulations. Hiring Philosophy
All Koch companies value diversity of thought, perspectives, aptitudes, experiences, and backgrounds. We are Military Ready and Second Chance employers. Learn more about our hiring philosophy here. Who We Are
As a Molex company, Phillips Medisize mobilizes and deploys specialized capabilities and services across highly regulated industries, including health care, regulated consumer, automotive and defense. We design, develop and create innovative and life-changing medical technologies for millions of people around the globe. Our Benefits
Our goal is for each employee, and their families, to live fulfilling and healthy lives. We provide essential resources and support to build and maintain physical, financial, and emotional strength - focusing on overall wellbeing so you can focus on what matters most. Our benefits plan includes - medical, dental, vision, flexible spending and health savings accounts, life insurance, ADD, disability, retirement, paid vacation/time off, educational assistance, and may also include infertility assistance, paid parental leave and adoption assistance. Specific eligibility criteria is set by the applicable Summary Plan Description, policy or guideline and benefits may vary by geographic region. If you have questions on what benefits apply to you, please speak to your recruiter. Equal Opportunities Equal Opportunity Employer, including disability and protected veteran status. Except where prohibited by state law, all offers of employment are conditioned upon successfully passing a drug test. This employer uses E-Verify. Please visit the following website for additional information: http://www.kochcareers.com/doc/Everify.pdf #LI-SD5
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