Principal Design Quality Engineer

Medtronic is working with new partners, in new ways to improve global healthcare. With the integration of Covidien as our Minimally Invasive Therapies Group, we can address the healthcare needs of more people around the world than ever.

The Principal Quality Design Engineer, as a member of the Design Quality organization within MITG’s Early Technologies Business will report directly to the VP of Quality Design and Regulatory Affairs. This individual will be responsible to advance quality program in support of departmental, functional, site, and corporate quality goals and priorities. Provides focused quality engineering support for new and existing products, manufacturing operations and quality process/system. The scope of product responsibilities is catheter and electronic capital equipment. The Quality organization ensures that all products designed and manufactured within GI Solutions meet regulatory, quality, and customer requirements and expectations. Quality Design liaises with managers and staff throughout the organization to ensure Quality System compliance and the highest level of product quality. What is the work you will be doing? ESSENTIAL DUTIES AND RESPONSIBILITIES: - Partner with R&D on Risk Management activities for NPD Projects: Complete Product Family Risk Plan, System Hazard Analysis, DFMEA, Risk Management Report. Work with Manufacturing to complete PFMEA. - Review and provide feedback for NPD Projects for items including but not limited to: I/O Matrix, Drawings/Specifications, Engineering Studies, Design Verification and Validation Protocols & Reports, Manufacturing Process Instructions (MPI), Process Validation studies. - Participate as resource in validations applicable to processes and product. - Proactively investigate, identify, and implement best-in-class Quality Engineering practices. - Utilize standard and advanced statistical analysis techniques to determine test sample sizes, protocol development, evaluate process capabilities, and develop statistically sound tolerance limits. - Actively manage Key Performance Indicator (KPI) data metrics in assigned areas and administer technical investigation and corrective action programs to resolve recurring quality problems. - Support Manufacturing Quality to develop, refine and document QA test and inspection procedures. - Provide technical guidance and training in statistical analysis techniques, experimental design and other QA Engineering areas of expertise. - Review drawings for inspection points. Recommend inspection points based on FMECA criticality analyses. - Assist in the development and/or write protocols and perform validations/verifications as necessary. - Support various engineering teams to include Risk Management, Usability Assessments, and Clinical Evaluations. - Support CAPAs as required. Establish effective corrective action plans and drives towards timely closure and effectiveness. - Participate in the non-conformance reporting system, driving timely disposition and closure. Identify non-conformance trends and develop and administer technical investigation and corrective action programs to resolve recurring quality problems. - Provide support to audits (FDA, DGM, UL, international representatives) and ensure the execution of corrective action and compliance with internal quality procedures and external standards. - Periodically draft, review and revise Quality System Procedures or other department operating procedures and assume accountability for all such procedures in the assigned areas. - Actively support and participate on Manufacturing and Design Engineering teams to address supplier issues. - Actively monitor post market surveillance data in assigned areas (i.e. complaints/MDRs), participate in complaint analysis as needed, and proactively administer technical investigation and corrective action programs to resolve recurring quality problems. - Communicate with external test agencies such as UL for Certification of New Products. - Participate in root cause analysis/failure investigations when necessary. - Lead and/or support Quality Improvements and Legacy Projects as needed. - Support activities related to Medtronic Integration and any other areas such as Risk Management, Process Validation, Test Method Validations. - Support Standards Updates for adherence to latest & greatest versions of Product Standards and Quality System Standards. Examples of such Standards include: IEC 606101, ISO 13485, ISO 14971 etc.

Qualifications Do you have these experiences or skills? - Solid knowledge and track record in the application of Design Controls, Risk Management and Statistics towards supporting New Product Development and sustenance of Class II (and/or III) Devices. - Training and/or certification in Six Sigma Black Belt, preferred. - Internal and External Audit experience, preferred. - Experience and excellent track record in effective communication, planning and cross-functional collaboration. - Experience in making critical decisions that prioritize patient care/safety and FDA regulations while supporting smart business decisions. - Effective team player with strong communication skills and track record of completing commitments with cross functional resources from R&D, Marketing, Regulatory Affairs, Manufacturing and/or other departments. - Strong planning, partnering and organizational skills. - Strong data management skills. - Strong computer skills with specific experience with Microsoft Word, Excel, Project, Adobe Acrobat, QAD or equivalent. Do you have these professional or academic certifications? - Bachelors or higher advanced degree in Biomedical, Mechanical, or Chemical Engineering, or related field. CQE certification preferred - Minimum 8 years of related experience in Medical Device or other regulated healthcare industry - Team leadership experience preferred - Demonstrated use of Quality tools/methodologies - Ability to apply advanced statistics - Comprehensive knowledge and experience with the CAPA, Complaint Analysis and Internal Audit processes - Risk Management expertise - Disposable devices and electronics background preferred - Strong working knowledge of 21CFR Part 820 and ISO13485, ISO 14971 and EN46001