Director of Engineering, MedTech Job Description Template

The director of engineering in a medtech organization leads the teams building regulated products, accountable for delivery, technical quality and the engineering side of the quality system. The role has to reconcile commercial pressure for speed with a development process that cannot be shortened without consequence, and much of the leadership value is in holding that line credibly.

Typical Duties and Responsibilities

• Lead engineering teams across software, firmware and systems
• Own delivery of the engineering roadmap within the quality system
• Ensure design control obligations are met without unnecessary overhead
• Set technical standards and review architecture decisions
• Hire, develop and retain engineers in a specialized market
• Work with quality and regulatory on process improvement
• Support regulatory submissions with engineering documentation
• Manage engineering budget, tooling and vendor relationships
• Lead investigation of field issues and corrective actions
• Represent engineering to executive leadership

Education

• Bachelor’s degree in engineering or computer science

Required Skills and Experience

• 8+ years of engineering experience with 3+ leading teams in medical devices
• Deep familiarity with design controls, IEC 62304 and ISO 13485
• Track record delivering products through regulatory clearance
• Ability to defend necessary process against schedule pressure
• Experience hiring specialized engineering talent
• Strong technical judgment across software and hardware
• Clear communication with quality, regulatory and commercial functions
• Experience leading field issue investigations

Preferred Qualifications

• Experience with Class II and Class III devices
• Background spanning both software and hardware