Senior Complaint Engineer – Medical Devices

USA - 3316 Takeda Development Center Americas, Inc.; Lexington (MA); On-site; USD 104,000 - 163,000; Full time

Job summary

Takeda in Lexington, MA seeks an Engineer IV, Complaint Analyst to lead and manage operations for medical device quality and compliance. The role involves designing, testing, and operating equipment to meet safety and performance standards, while contributing to device development and improvements.

You will drive design controls, risk management, and robust investigations, coordinating across internal teams and external partners to ensure timely complaint closure and regulatory adherence.

Qualifications

• Requires an engineering or science background with strong documentation skills.
• Experience in regulated lab/quality environments preferred.
• Ability to create clear investigation narratives supported by objective evidence.

Responsibilities

• Lead design control deliverables to comply with medical device regulations.
• Develop requirements and perform risk assessments.
• Log, triage, and investigate customer complaints and returned devices.
• Perform lab evaluation of returned products with proper biosafety controls.
• Lead root cause analysis and document results in eQMS.
• Initiate and support CAPA/nonconformance activities.
• Collaborate with external partners on technical issues.
• Lead project workstreams and mentor junior engineers.

Skills

Design controls

Risk management

Root cause analysis

eQMS documentation

CAPA

Project leadership

Regulatory compliance

CAD tools

Mechanical engineering

Electrical engineering

Education

Bachelor's degree in Engineering

Associates degree + 4+ years experience

Tools

CAD tools

eQMS

Job description

Takeda in Lexington, MA seeks an Engineer IV, Complaint Analyst to lead and manage operations for medical device quality and compliance. The role involves designing, testing, and operating equipment to meet safety and performance standards, while contributing to device development and improvements.

You will drive design controls, risk management, and robust investigations, coordinating across internal teams and external partners to ensure timely complaint closure and regulatory adherence.