Principal Supplier Quality Engineer Katalyst Healthcares & Life Sciences - 4.0 Arden Hills, MN Job Details Contract 17 hours ago Qualifications Developing medical devices Accreditation standards (regulatory compliance area) Preventive action implementation Corrective and preventive actions (CAPA) Project management experience in manufacturing ISO certification audits Vendor compliance audits Production validation processes Quality risk management Medical device manufacturing facility experience Design engineering Data interpretation Regulatory/legal compliance standards in production Data-driven problem-solving Engineering product development Design controls Biomedical regulatory compliance Managing projects Manufacturing Cross-functional team management Cross-functional communication

Full Job Description Job Description:

This person must be able to travel 5-10% globally (possibly Sweden, China, Finland, also local.) Approximately 5-10 trips per year. As a Principal Supplier Engineer, you'll be the bridge between Boston Scientific Cardiac Diagnostics (CDx) cutting-edge design leading the integration of new and existing technologies into CDx's global supply chain. Your work will directly impact the reliability, scalability, and speed at which life-changing devices reach patients. As the technical lead, you'll work with R D, Quality, Operations, and Regulatory team members to integrate OEM and sub-system supplier designs along with supplied components into CDx's products to ensure compliance, performance, and safety requirements are met. This role has a wide scope of responsibilities ranging from ensuring supplier design assurance, supplier product development integration assurance, and third-party manufacturing assurance.

Responsibilities:

Working with Medical Device OEM, sub-system and component suppliers to identify supplier specifications with the end goal of successfully integrating supplied designs and components into CDx's development and manufacturing processes. Partnering with R D, Design Assurance, Manufacturing Engineering, Operations Quality, and Project Management to execute supplier control deliverables according to program needs, such as purchased material qualifications, supplier-driven change assessments, supplier design or capability improvement projects, or regulated compliance assessments. Generating and reviewing quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations. Investigating complaints and managing supplier investigations for both design and manufacturing-related issues. Participating in supplier audits to assess design and manufacturing compliance to regulatory standards and CDx agreed specification requirements. Audit activities include the evaluation of audit observations and findings, reporting, follow-up, and confirmation of follow-up actions. Acting as a technical expert to ensure repeatable and reproducible quality/reliability during the life of the product.

Requirements:

Bachelor's degree in engineering or related discipline. 7+ years of technical experience working in Medical Device development processes. Experience in design controls, risk management, process validation, and CAPA. Design Assurance experience. Component and supplier qualification experience. Strong Project Management skills. Auditor of

ISO 13485

quality systems (ISO 13485 Certified Auditor preferred). Self-driven and results oriented with strong data analytics and critical thinking skills. Experience managing projects and working with cross-functional teams to drive deliverables. Experience working with suppliers and familiar with the application of design controls and supplier controls as per 21CFR820 and MDR. Supplier design assurance, supplier product development integration assurance, and third-party manufacturing assurance.