Senior Quality Engineer

The Quality Engineer, New Product Development, will leverage expertise in quality engineering principles and methodologies to ensure compliance with regulatory standards and the company’s systems/procedures, optimizing product development, internal and external device manufacturing, and device distribution. Responsibilities Provide engineering solutions in Quality Assurance, Design Controls, Risk Management, and Statistical Techniques. Lead design assurance and development activities (e.g., engineering studies, feasibility testing, drawing reviews) for new product development programs. Lead the creation and maintenance of risk management files per ISO 14971 and applicable regulations (plans, hazard analyses, FMEAs, software hazard analysis, reports). Develop quality assurance specifications, test methods, inspection procedures, sampling plans, and related documentation. Lead test method development and validation activities. Support new product launches, master validation plans, product V&V, process validations, and design transfer into manufacturing. Provide daily support to production needs and issues through active involvement in assembly operations, continually improving methods and systems to ensure full compliance and world-class manufacturing standards. Implement and review changes to existing products, SOPs, Work Instructions, Test Methods, Process Changes, Design Changes, Labeling, and Field Issues to determine requirements for regulatory submissions and notifications. Prepare and support documentation for regulatory submissions and global registrations. Support the Supplier Evaluation, Selection, and Qualification processes. Perform additional duties as required. Qualifications Bachelor's Degree in Engineering or a related scientific field with 4 years of experience in Quality Engineering, Quality Manufacturing, and/or R&D; OR Master's Degree in Engineering or a related scientific field with 2 years of relevant experience. Hands-on experience with Design Assurance, including Design Controls, Design Freeze (or pre-design freeze feasibility testing), Design Verification & Validation, and/or Design Test Method Development. Experience working in a highly regulated industry. Working knowledge of Software Development Life Cycle Processes in accordance with IEC 62304, highly preferred. Working knowledge of Usability Engineering Processes in accordance with IEC 62366, highly preferred. Job Type: Full-time Pay: $115,000.00 - $140,000.00 per year Benefits: 401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance Schedule: Monday to Friday Application Question(s): What are your salary requirements? Experience: ISO 9001: 1 year (Preferred) Catheter: 1 year (Preferred) NPD: 1 year (Preferred) Hands on Design Assurance: 1 year (Preferred) Work Location: In person