Design controls and regulatory submission expertise
Human factors engineering and risk management
This role leads the global Device Development organization responsible for end-to-end delivery of device and combination product engineering from early feasibility through launch
Job Summary
This role leads the global Device Development organization responsible for end-to-end delivery of device and combination product engineering from early feasibility through launch.
The successful candidate will own the enterprise device strategy, ensuring compliant regulatory submissions and robust supplier ecosystems across global markets.
Takeda offers a competitive base salary range of $259,000.00 - $407,000.00 along with comprehensive benefits including medical, dental, vision, and 401(k) matching.
Matching Summary
This role leads the global Device Development organization responsible for end-to-end delivery of device and combination product engineering from early feasibility through launch.
Salary
Base: $259,000.00 - $407,000.00; Bonus/Equity: Eligible for short-term and long-term incentives; Benefits: Medical, dental, vision, 401(k), disability, life insurance, tuition reimbursement
Skills & Requirements
Must-have
Global device and combination product development
Design Controls and regulatory submission expertise
Human factors engineering and risk management
Supplier ecosystem and quality agreement management
Tech transfer and manufacturing industrialization
ISO 13485 and FDA device requirements knowledge
Nice-to-have
Digital engineering and model-based design skills
Strategic partnership and innovation leadership
Cross-functional team building and diversity mindset
Experience with connected device technologies
Ability to drive organizational change and culture