Senior Device Engineer, Drug Delivery Systems

Takeda; Lexington (MA); On-site; USD 137,000 - 215,000; Full time

Benefits offered by this job

Healthcare (Medical, Dental, Vision)

401(k) with company match

Annual Retirement Contribution Plan

Onsite flu shots and health screenings

Generous vacation time off

Charitable contributions matching

Family planning support

Flexible working arrangements

Tuition reimbursement

Job summary

Takeda is seeking a Sr. Staff Device Engineer in Lexington, MA to act as the device SME for on-market combination products.

You will lead lifecycle management, change controls, and manufacturing validation while coordinating with drug product, quality, and regulatory teams in a cross-functional environment. You will oversee device qualification, tech transfer, CAPA and post-market surveillance, ensuring compliance with cGMP and ISO standards for drug delivery devices.

Qualifications

• PhD with 3+ years, MS with 5+ years, or BS with 8+ years related experience.
• SME in medical devices, especially drug delivery systems, with technical leadership.
• Knowledge of design controls and quality system requirements.
• Experience in lifecycle management for combination products including complaint handling and change control.
• Knowledge of cGMP and regulatory guidance for device/combination products.

Responsibilities

• Lead lifecycle management for commercial combination products as device SME.
• Coordinate tech transfer, verification and validation for new drug delivery devices.
• Provide input on change controls, MDR and post-market surveillance reports.
• Lead risk management activities and project work within defined budgets.
• Oversee device qualification processes and manufacturing expansion activities.

Skills

Medical devices expertise

Drug delivery systems

Design controls

cGMP compliance

Cross-functional collaboration

Technical leadership

Education

PhD in Mechanical, Electrical or Biomedical Eng

MS in related field

BS in related field

Job description

Takeda is seeking a Sr. Staff Device Engineer in Lexington, MA to act as the device SME for on-market combination products.

You will lead lifecycle management, change controls, and manufacturing validation while coordinating with drug product, quality, and regulatory teams in a cross-functional environment. You will oversee device qualification, tech transfer, CAPA and post-market surveillance, ensuring compliance with cGMP and ISO standards for drug delivery devices.