About this role
B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®. Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.bbraunusa.com POSITION SUMMARY: The Staff Quality Engineer primary focus is on Design Quality to support the development and lifecycle management of surgical medical device products. This role will provide quality engineering leadership across design controls, risk management, validation, DHF documentation, while also supporting broader quality system activities such as CAPA, complaints, supplier and contract manufacturer quality, audits, and production-related quality needs. The ideal candidate is an experienced quality professional who can provide strong guidance while also supporting broader quality and production-related needs. ESSENTIAL DUTIES AND RESPONSIBILITIES: • Participate in the review of design control activities, including design reviews, risk management, product requirements, software requirements, and usability engineering. • Provide strong quality engineering support for the review of hardware, software, biomedical engineering (BME), and computer system validation (CSV) activities, including the review of validation strategies, protocols, reports, and associated documentation. • Support in the review and maintenance of design history files (DHF) to ensure compliance with internal procedures and external regulations (e.g., FDA, ISO 13485). • Review risk management activities, including Hazard Analysis, FMEA (Failure Mode and Effects Analysis), ensuring appropriate risk mitigation strategies are identified and implemented. • Understand labeling, user requirements, instructions for use, indications for use documents and know how they are applied to the class device to be released for sale • Provide quality engineering support for CAPA activities, including performing investigations and implementation of actions, and executing verification of effectiveness to ensure solutions are sustained and compliant with FDA/ISO and internal requirements. • Review complaint investigations and risk analysis, including escalation to CAPA when needed. • Complete measurement system analyses and validates test methods as needed. • Supplier and Contract Manufacturer QA, including assessing, qualifying, auditing, drafting quality agreements, and monitoring suppliers and contract manufacturers to ensure compliance with applicable regulatory requirements, internal procedures, and product quality expectations. • Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory Affairs, Marketing) to ensure quality objectives are met. • Participate in internal and external audits (e.g., Internal Audits, Notified Body). • Develop and implement quality plans, procedures, and work instructions to enhance the effectiveness of the quality management system. • Mentor other quality personnel and provide technical guidance on design quality principles and practices. • Contribute to continuous improvement initiatives within the quality organization, identifying opportunities for process optimization. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education/Experience Required: • Bachelor's degree with a minimum of 8 years of experience, or a higher degree with a minimum of 6 years of experience in Biomedical, Mechanical, Electrical, or Industrial Engineering or other equivalent science/engineering degree from an accredited university. • 8+ years’ experience in Design Quality Engineering within the medical device with demonstrated expertise in design controls, risk management and regulatory compliance for exoscope-robotic medical devices • Deep understanding of design control requirements (QMSR (21 CFR Part 820), ISO 13485 and risk management - ISO 14971) • Strong analytical and problem-solving skills with the ability to investigate complex issues • Effective written and verbal communication skills • Ability to work both independently and collaboratively in a fast-paced environment Desirable • Master’s degree in Engineering • ASQ certification (CQE, CQA) • ISO 13485, and Medical Device Regulation (MDR) Salary Range: $150,000 - $190,000 The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate. B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com . Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. 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