Lead Commercial Drug-Delivery Device Engineer

USA - 3316 Takeda Development Center Americas, Inc.; Lexington (MA); On-site; USD 137,000 - 215,000; Full time

Benefits offered by this job

Comprehensive Healthcare

401(k) with company match

Health & Wellness programs

Generous vacation time

Community outreach

Family planning support

Flexible working

Tuition reimbursement

Job summary

Takeda is seeking a Commercial Device Technical Lead in Lexington, MA to drive lifecycle management of drug delivery devices. You will work with cross-functional teams across manufacturing, QA, regulatory, and program leadership to ensure successful tech transfer and post-market activities.

The role emphasizes design controls, risk management, and strong problem solving in a fast-paced environment, with opportunities to lead high-impact device programs within the Takeda device development

Qualifications

• SME in medical devices, especially drug delivery systems.
• Experience leading drug delivery device products to commercialization.
• Knowledge of design controls and quality systems (ISO 13485, MDR).
• Strong problem solving and cross-functional collaboration.

Responsibilities

• Lead lifecycle management of commercial device products.
• Coordinate tech transfer of verification/validation activities.
• Support change control, MDR, and post-market surveillance.
• Oversee risk management and CAPA activities.
• Draft technical content: user requirements, protocols, reports.

Skills

Technical leadership

Cross-functional

Risk management

Design controls

cGMP knowledge

Regulatory guidance

LCM - life cycle management

Quality system knowledge

Root cause analysis

CAPA

Tech transfer

Test method development

Education

PhD in Mechanical / Electrical / Biomedical Engineering

Master’s with experience

Bachelor’s with experience

Tools

Design verification tools

Documentation systems

Job description

Takeda is seeking a Commercial Device Technical Lead in Lexington, MA to drive lifecycle management of drug delivery devices. You will work with cross-functional teams across manufacturing, QA, regulatory, and program leadership to ensure successful tech transfer and post-market activities.

The role emphasizes design controls, risk management, and strong problem solving in a fast-paced environment, with opportunities to lead high-impact device programs within the Takeda device development