Design Assurance Engineer

About Us CPC is the global leader in fluid connection technologies. Throughout our nearly 50-year history, we’ve succeeded by focusing on customer needs, engineering innovative solutions, and creating a positive, high-performance work environment. Our collaborative, talented team is fully dedicated to helping our customers achieve their goals. CPC’s technical expertise and commitment to quality makes effective, optimized fluid management possible across a wide range of applications. Today, CPC serves biopharmaceutical, thermal management (liquid cooling of electronics), medical, industrial, and chemical handling markets. Our breadth and depth of knowledge in low-pressure connectors empowers us to recommend the right solution even in the most demanding fluid management requirements. CPC has offices in 14 countries and nearly 200 distributor partners around the world. CPC is a Dover company. Your Role Are you ready to make an impact? As a Design Assurance Engineer you will play a pivotal role in shaping our organization’s success. You will work closely with our dedicated teams to develop effective solutions that align with CPC’s strategic goals. This is more than just a job; it’s an opportunity to grow, learn, and thrive in a supportive environment. Responsibilities: Risk Management SME: Lead cross-functional meetings to ensure Market Needs, Engineering Spec and risk are aligned and mitigated or properly justified for leadership approval and identify process risks for both internal and external manufactured parts and assemblies (e.g., FMEA (Failure Modes Effects Analysis). Provide feedback on new tests or test methods to resolve measurement discrepancies and ensure correlation in measurement method between in-process, Receiving Inspection and Risk Management in compliance with CPC requirements. For example, if a new test is required to mitigate a risk identified in Risk Management the NPI QE needs to be involved in the development and approval of that new test method. Attend team meetings and provides Quality Engineering input for potential design, process, and project risks. Provide input to Design Engineering on new component technology and assist in component selection with quality and reliability analysis. Support Design/Service Transfer by providing input to design and manufacturing, Project Management and Supply Chain including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that new and refurbished tools and associated processes result in products that can be adequately manufactured and tested Review and develop design control documentation for accuracy, completeness and user-friendly content that meets the needs of target audience in support of device history records and device master records. Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, & PQ). Collaborate cross-functionally as NPI Quality Engineer; a Core Team Member, on new product/service development teams to ensure conformance with CPC QMS and lead deviation justification if necessary. Provides Statistical recommendations for formal DVT and Characterization testing as well as for process and other informal testing Collaborate with suppliers and applicable CPC functional teams in developing statistically valid, highly capable, repeatable, and reproducible test methods for formal DVT, Characterization and other informal testing. Develop validation plans and protocols to verify that components and supplier product meets requirements. Review and approve DVT test protocols. Provide data driven feedback on results. Review and approve process verification/validation test plans, protocols, reports, inspection procedures and associated documentation. Provide data driven feedback on results to resolve measurement discrepancies and ensure correlation in measurement method between in-process and Receiving Inspection in compliance with CPC requirements. Ensure correlation in measurement method between in-process and Receiving Inspection in compliance with CPC requirements. Problem Solving and Root Cause Analysis SME; Lead cross-functional meetings to investigate design-related issues (DVT failures), Facilitate, and conduct root cause analysis, Facilitate implementation and effectiveness of corrective and preventive actions (CAPA). Ensure traceability between design inputs, outputs, and test results. Performs other job duties as assigned to meet business needs. Basic Requirements: ~ Bachelor's Degree in Engineering required. ~10 years of experience in Quality, Manufacturing, or related field. ~ Proficient with Quality System Regulations and ISO Quality System Standards. ~ Strong understanding of ISO 13485 and ISO 9001. ~ Excellent analytical decision making and problem-solving skills. ~ Proven ability to resolve issues and participate in process improvement activities. ~ Ability to define problems, collect data, establish facts and draw conclusions. ~ Superb written communication skills, with a keen eye for detail and focused on target audience. ~ Ability to effectively present information in one-on-one and small group situations. Our Culture At CPC, we believe that our people are our greatest asset. We foster a culture of respect, collaboration, and high ethical standards, where everyone is empowered to share ideas and grow together. Growth & Development We’re dedicated to your professional journey. Our team provides mentorship and resources to help you develop your skills and advance your career. Whether you’re new to the industry or a seasoned professional, we welcome your unique perspective. Work/Life Balance We understand the importance of balancing person and professional commitments. CPC operates on a Monday-Friday schedule, with opportunities for 1st and 2nd shift in production and warehouse roles. In addition, we offer generous paid time off, including company-paid holidays and volunteer time, to help you recharge and give back to your community. Benefits & Compensation At CPC, we offer a comprehensive benefits package, including but not limited to: Health & Welfare Benefits: Medical, Dental, Vision, HSA, FSA, Life Insurance, company-paid Long-Term & Short-Term Disability, Parental Leave, and wellness offerings including onsite gym. Retirement Plan: Generous company match, Profit-Sharing, Automatic Enrollment & Contributions Salary: $105,000 - $120,000/annual This range is the pay scale for this role in Minnesota. Individual compensation is based on skills, experience, and qualifications related to this position. Bonus Eligibility: Yes, 10% Travel: up to 20% Join Us If you’re ready to be part of an innovative team that values connection and collaboration, we want to hear from you! We are an equal-opportunity employer, and all qualified applicants will receive consideration for employment. We consider several job-related, non-discriminatory factors when determining the pay rate for a position, including, but not limited to, the position’s responsibilities, a candidate’s work experience, a candidate’s education/training, the position’s location, and the key skills needed for the position. Pay is one of the Total Rewards that we provide to compensate and recognize employees for their work. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, genetic information, or any other factors prohibited by law. Work Arrangement : Onsite Sub Division : Quality Job Requisition ID : 59803 Job Function : Quality & Continous Improvement [AB1]