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 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.

At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.

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.

At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.

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

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