Head Of Device Development (vice President)

Takeda

Boston, MA, US
Base: $259,000.00 - $407,000.00; bonus/equity: eli...
Hybrid
Global device development leadership
Design controls and risk management expertise
Regulatory submission experience fda eu mdr
This role leads the global Device Development organization ensuring end-to-end delivery from early feasibility through commercial launch and sustaining engineering

Job Summary

  • This role leads the global Device Development organization ensuring end-to-end delivery from early feasibility through commercial launch and sustaining engineering.
  • The position requires deep expertise in Design Controls, regulatory submissions including IND/CTA/MAA/NDA/BLA, and managing complex supplier ecosystems globally.
  • Candidates must possess extensive industry experience with a demonstrated track record of successful product approvals and commercialization for device or combination products.

Matching Summary

This role leads the global Device Development organization ensuring end-to-end delivery from early feasibility through commercial launch and sustaining engineering.

Salary

Base: $259,000.00 - $407,000.00; Bonus/Equity: Eligible for short-term and long-term incentives; Benefits: Medical, dental, vision, 401(k), up to 120 hours vacation

Skills & Requirements

Must-have

  • Global device development leadership
  • Design controls and risk management expertise
  • Regulatory submission experience FDA EU MDR
  • Supplier ecosystem and quality agreements
  • Human factors and usability engineering
  • Tech transfer to manufacturing processes

Nice-to-have

  • Digital engineering and simulation capabilities
  • Innovation in build buy partner decisions
  • Cross-functional executive collaboration skills
  • Diversity and inclusion mindset demonstration
  • Model-based design proficiency

Key Requirements

  • 25+ years relevant industry experience
  • Bachelor's degree in engineering or related field
  • Masters degree with 20+ years experience
  • PhD with 15+ years experience
  • Proven global leadership in device development
  • Experience with ISO 13485 and ISO 14971 standards

Work Rights

Not specified

Tailored Resume

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