Design Assurance Engineer III - Electrophysiology

Work cross-functionally with R&D, project management, manufacturing, regulatory, clinical and marketing to ensure project success. Leads/supports the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input. Maintains product risk management documentation (i.e. Hazard Analysis & FMEAs). Leads/supports the development of and coordinates the execution and documentation of Design Validation and Verification activities. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Supports and leads the execution and investigation of CAPAs, NCEP, Complaints, Failure Mode Investigations, etc. Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards. Able to navigate gray space by applying risk-based criteria to prioritize project work. Support cross functional team through product life cycle process; specifically, with respect to design control and risk management deliverables. Minimum of a bachelor's degree in Materials, Mechanical, Electrical, Chemical, Biotechnology, Electromechanical or related field of study Minimum 4 years of experience in Quality Assurance and/or Design Assurance, Sustaining, R&D, Manufacturing or related medical device experience ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis Experience navigating design, manufacturing and/or supplier variations Strong understanding of NCEP/CAPA processes Previous experience working to create/maintain risk documentation such as FMEAs and HAs Experience working with Stature or FMEA MED-8 software Self-motivated with a passion for solving problems and a bias for action Ability to manage multiple priorities and work with ambiguity Strong communication skills (verbal & written) Proficiency in collaborating with interdisciplinary teams Familiar with EP environment