Engineering Director (Medtech)

TL;DR

Engineering Director (Medtech): Leading the New Product Development Risk Management and Reliability Quality team for medical devices with an accent on strategic leadership, risk management, and regulatory compliance. Focus on ensuring patient safety across the full product lifecycle and developing high-performing quality engineering teams.

Location: Must be based in the USA (Mounds View, MN; Lafayette, CO; North Haven, CT; or Boston, MA)

Salary: $198,400 – $297,600

Company

A global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life through innovative medical technologies.

What you will do

• Lead and develop the Surgical Operating Unit’s New Product Development Risk Management and Reliability Quality team.
• Provide strategic leadership to align team goals with broader business objectives and prioritize departmental initiatives.
• Direct the design and development of safe, effective, and compliant medical device products.
• Establish performance goals, conduct reviews, and mentor talent to drive functional excellence.
• Oversee the creation and maintenance of risk management files and reports in compliance with regulatory standards.
• Manage departmental budgets and resource allocation across functions.

Requirements

• Bachelor’s degree in Engineering or a related technical field.
• Minimum of 10 years of experience in Quality New Product Development (or 8 years with an advanced degree).
• 7+ years of demonstrated people leadership and managerial experience.
• Unrestricted U.S. work authorization is required.
• Strong expertise in reliability science, risk management, and design controls.

Nice to have

• Certified Quality Engineer (CQE) or Six Sigma Green Belt certifications.
• AAMI design control certification.
• Deep understanding of ISO 14971, ISO 13485, IEC 62304, and FDA Part 820.
• Experience working within a matrixed organization.

Culture & Benefits

• Comprehensive health, dental, and vision insurance with HSA and FSA options.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and short-term disability.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan and global well-being program (Simple Steps).