Engineering Director

• Lead and develop the Surgical Operating Unit’s New Product Development Risk Management and Reliability Quality team
• Provide strategic leadership to prioritize departmental initiatives and align team goals with broader business and functional objectives
• Establish performance goals and targets, conduct performance reviews, and lead regular one‑on‑one discussions to support employee development and performance management
• Direct and guide employees in the design and development of medical device products and systems
• Develop, implement, and continuously improve objectives, policies, processes, and standards to support business strategy and drive functional excellence through best practices
• Select, hire, and develop talent, ensuring the right capabilities are aligned to the right programs and roles for efficient and effective team performance
• Collaborate effectively across functions and businesses, balancing competing priorities and influencing stakeholders to achieve shared outcomes
• Manage the departmental budget and ensure effective allocation of resources
• Lead the team in creating and maintaining the risk management file, including risk management plans and reports, and conducting regular risk reviews
• Ensure quality deliverables for new product development activities are executed in compliance with applicable regulatory requirements and internal quality standards
• Serve as a key quality leader in the medical device development process, with a strong focus on patient safety across the full product lifecycle

• Bachelor of Engineering or technical degree required
• Minimum of 10 years of relevant experience which includes experience in Quality New Product Development or advanced degree with a minimum of 8 years of experience
• 7+ years of managerial experience to include demonstrated people leadership experience
• Strong background in Quality New Product Development
• Expertise in reliability science, risk management, design controls, and regulatory compliance
• Ability to work effectively in cross‑functional teams and influence across a matrixed organization
• Strong initiative, curiosity, learning agility, and problem‑solving skills
• Expertise in quality management systems and statistical methods and analysis
• Certifications:
  
  Certified Quality Engineer (CQE)
• Six Sigma Green Belt or equivalent certification
• AAMI design control certification
• Industry
  
  Experience:
  
  Medical device industry experience
• Understanding of relevant regulatory requirements, including ISO 14971, ISO 13485, IEC 62304, and FDA Part 820
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Demonstrates expertise in Quality New Product Development, Risk Management, and Regulatory Compliance within the medical device industry, while effectively leading cross‑functional teams to achieve strategic objectives and ensure patient safety throughout the product lifecycle.