Senior Complaint Engineer – Medical Devices & CAPA Lead

Takeda; Lexington (MA); On-site; USD 104,000 - 163,000; Full time

Job summary

Takeda in Lexington, MA seeks an Engineer IV, Complaint Analysts to lead engineering operations for medical devices, ensuring quality, cost, safety, reliability, and performance. You will design, construct, test, and operate equipment while contributing to product development and Takeda's mission to improve health.

You will manage complaint investigations, lead design verification, and collaborate with cross-functional teams and external partners to ensure regulatory compliance and timely CAPA

Qualifications

• Associates degree with 4+ years relevant experience or a Bachelors in Engineering, Chemistry, Biology, or related technical field with 2+ years relevant experience.
• Experience in a regulated laboratory or quality environment preferred.
• Strong technical writing to document investigations with objective evidence in the eQMS.

Responsibilities

• Lead and manage engineering operations for medical devices, ensuring quality, safety, reliability, and performance standards.
• Develop design control deliverables to comply with medical device regulations and perform risk assessments.
• Receive, log, triage customer complaints and returned devices, perform root cause analysis and document in eQMS.
• Coordinate lab evaluation of returned products and perform analysis using structured problem solving and data trending.
• Lead project workstreams, act as a technical SME, and collaborate with external partners.

Skills

Technical writing

Design verification

Risk management

Regulatory compliance

Project management

Leadership

Cross-functional collaboration

CAD

Troubleshooting

Data analysis

Education

Associates degree +4 years experience or Bachelors in Engineering, Chemistry, Biology or related with 2+ years experience

Tools

CAD tools

Job description

Takeda in Lexington, MA seeks an Engineer IV, Complaint Analysts to lead engineering operations for medical devices, ensuring quality, cost, safety, reliability, and performance. You will design, construct, test, and operate equipment while contributing to product development and Takeda's mission to improve health.

You will manage complaint investigations, lead design verification, and collaborate with cross-functional teams and external partners to ensure regulatory compliance and timely CAPA