Sr Design Assurance Engineer

B. Braun Medical Inc., a leader in the healthcare industry, is seeking a Sr Design Assurance Engineer to join our dynamic Quality Assurance & Testing team. This role is pivotal in supporting the design and development of medical devices and products by ensuring they meet both internal company standards and external regulatory requirements. The position focuses on enhancing safety and efficacy in all product outputs, aligning with our mission to improve patient and clinical outcomes while minimizing environmental impacts.

Responsibilities

• Lead risk management activities throughout the product lifecycle, from design to market release.
• Collaborate with cross-functional teams including R&D, Operations, and Marketing to ensure product compliance with all quality standards and regulatory requirements.
• Develop and implement quality standards and validation processes for new medical products.
• Conduct root cause analysis and implement corrective actions for product and process issues.
• Oversee the preparation and submission of regulatory filings and participate in regulatory agency audits.
• Monitor the performance of and improve upon quality assurance testing methodologies.
• Mentor and lead junior engineers and technicians in best practices and company procedures.

Required Skills

• Expertise in Quality Management Systems (e.g., ISO 13485, FDA regulations)
• Strong proficiency in risk management tools such as FMEA, Fault Tree Analysis
• Excellent analytical skills and a methodical mind
• Capable of statistical analysis and using statistical tools for product improvements
• Strong communication and leadership skills
• Adept in project management and capable of managing multiple projects simultaneously