Arthrex

Compensation

Full Description

Job Title: Engineer Sr. I - QA Design (Remote) Company Overview: Arthrex, Inc. is a global leader in the medical device industry, renowned for its innovative product development and commitment to medical education. As a privately held company, Arthrex is dedicated to its mission of Helping Surgeons Treat Their Patients Better™ by delivering high-quality, reliable medical solutions worldwide. Role Overview: As a Senior Engineer in QA Design, you will play a critical role in ensuring the quality and compliance of our medical device designs. You will collaborate closely with cross-functional teams to drive quality assurance processes and support the development of safe, effective products that meet regulatory standards. What You'll Do: - You will lead design quality assurance activities to ensure compliance with industry standards and regulatory requirements. - You will develop and execute test plans and protocols to validate product designs. - You will collaborate with engineering and product development teams to identify and mitigate design risks. - You will review design documentation and provide feedback to improve product quality. - You will support root cause analysis and corrective actions for design-related issues. - You will contribute to continuous improvement initiatives within the QA design process. - You will maintain up-to-date knowledge of regulatory requirements and industry best practices. - You will mentor junior engineers and share expertise to enhance team capabilities. What You Bring: - Minimum of 5 years of experience in quality assurance or design engineering within the medical device industry. - Strong knowledge of FDA regulations, ISO 13485, and other relevant quality standards. - Proficiency in design control processes and risk management techniques. - Experience with test plan development, execution, and documentation. - Excellent problem-solving skills and attention to detail. - Effective communication and collaboration skills to work across teams. Bonus Points If You Have: - Experience with software validation and verification in medical devices. - Familiarity with statistical analysis and quality tools such as Six Sigma or Lean methodologies. - Advanced degree in engineering or related field. - Previous experience mentoring or leading engineering teams. What We Offer: - We offer a competitive salary and comprehensive benefits package. - We offer flexible remote work options to support work-life balance. - We offer opportunities for professional growth and development. - We offer a collaborative and inclusive company culture. - We offer the chance to make a meaningful impact in healthcare through innovative medical technologies. Ready to Apply? Please submit your resume and cover letter through our careers page at www.arthrex.com/careers. We look forward to learning how you can contribute to our mission of Helping Surgeons Treat Their Patients Better™.