Senior Complaint & Quality 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 is seeking an Engineer IV, Complaint Analyst to lead engineering operations for medical devices. You will design, test, and operate equipment to meet quality, cost, safety, reliability, and performance standards, supporting device development and regulatory compliance.

You will develop design verification protocols, manage complaints end-to-end in the eQMS, and coordinate CAPA activities while collaborating with external partners to ensure timely delivery and adherence to

Qualifications

• Associates degree with 4+ years experience or Bachelor's degree with 2+ years experience.
• Experience in a regulated laboratory/quality environment preferred.
• Technical writing capability—clear investigation narratives with objective evidence in the eQMS.
• Strong collaboration, prioritization, and communication to coordinate cross-functionally and meet timelines.
• Able to work independently with supervisor support.
• Applies advanced project management skills to oversee device development projects.
• Knowledge of risk management to evaluate and mitigate design risks.
• Experience in mechanical and electrical engineering and CAD tooling.
• Proficient in design verification and regulatory compliance.

Responsibilities

• Support the device technical team in creating design control deliverables to comply with medical device regulations.
• Develop user, product, and system requirements, and perform risk management evaluations.
• Receive, log, and triage customer complaints and returned devices/combination products per procedures and timelines.
• Coordinate laboratory evaluation of returned products with biosafety controls.
• Lead root cause analysis using structured problem-solving and data trending.
• Document complaint handling end-to-end in the eQMS with investigation results and conclusions.
• Determine complaint outcomes and support reportability assessments and escalation.
• Initiate CAPA and nonconformance records with containment actions.
• Identify, collect, and interpret evidence from manufacturing history and data.
• Lead project technical workstreams and liaise with external partners.

Skills

Technical writing

Cross-functional collaboration

Project management

Risk management

Mechanical engineering

Electrical engineering

Design verification

Regulatory compliance

Prototype testing

Mathematical modeling

Leadership

Education

Associate degree

Bachelor's degree in Engineering/Science

Tools

CAD tools

Job description

Takeda in Lexington, MA is seeking an Engineer IV, Complaint Analyst to lead engineering operations for medical devices. You will design, test, and operate equipment to meet quality, cost, safety, reliability, and performance standards, supporting device development and regulatory compliance.

You will develop design verification protocols, manage complaints end-to-end in the eQMS, and coordinate CAPA activities while collaborating with external partners to ensure timely delivery and adherence to