Senior R+D Quality Engineer

JOB SUMMARY: The Senior R + D Quality Engineer implements and enforces quality standards that align with industry best practices and regulatory requirements that are aimed at insuring robust and quality design and manufacturability of medical devices. ESSENTIAL/PRIMARY DUTIES: * Plans, leads, and manages quality deliverables on new product development (NPD) projects in accordance with regulatory standards ISO9001:2015, ISO13485:2016, ISO14971, FDA, CSA, and EU MDR regulations. * Acts as a recognized expert in risk management, leads all risk management processes and creates risk management documentation for (NPD) projects. * Acts as a recognized expert in design controls and creates, reviews, and approves documentation related to the engineering Product Realization Process (PRP). * Acts an expert in the design and process failure mode and effects analysis (FMEA) process and trains other engineers in the FMEA process. * Leads site-based quality department initiatives as a subject matter expert (SME). * Applies domain mastery to the application and advancement of engineering methods and tools. * Champions six sigma techniques and drives standardization through continuous process improvement. * Collaborates with leadership and other cross functional departments to align decisions with organizational goals. * Mentors engineer II & III teammates, focusing on technical skills, leadership skills, and cultural competencies. * Formulates solutions to complex and ambiguous problems that aren't well defined. Incorporates feedback and solutions from others. SECONDARY DUTIES: * Supports internal and external quality system audits. * Creates threat models and cybersecurity risk assessments with limited guidance. * Facilitates the creation and maintenance of the products Usability Engineering Files, provides misuse cases involving use error and assesses the impact. * Leads the creation of the reliability predictions for projects with recommended testing profiles and analyzes test results. EDUCATION and/or EXPERIENCE: Bachelor's degree in engineering or related field and 8+ years of experience, or equivalent combination of both. Certified Quality Engineer (CQE), Six Sigma Blackbelt (DMAIC, DMADV), and Certified Reliability Engineer (CRE) certifications preferred. COMPETENCY and/or SKILL: * Experience in the medical device industry and understanding of medical device quality systems and applications is desired. * Ability to effectively influence and negotiate with all levels of an organization and lead effective/successful change initiatives. * Mastery of software programs - Microsoft Word, PowerPoint, Excel, Project, Minitab * Strong written and verbal communication skills * Expert problem solver in areas of expertise. * Ability to lead the design of complex, interconnected systems and shape the organization's technical direction. SUPERVISORY RESPONSIBILITIES: * Provides leadership, coaching, and/or mentoring to level II and level III engineers.

Created: 2026-04-02