Senior Complaint Analysis Engineer - Medical Devices

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

Job summary

Takeda Pharmaceutical Co. 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, safety, and performance standards, while handling customer complaints and supporting CAPA and nonconformance processes. The role requires advanced project management, risk assessment, and collaboration across cross-functional teams.

Qualifications

• Associates degree with 4+ years relevant experience or Bachelor’s degree in Engineering, Chemistry, Biology, or related scientific/technical discipline with 2+ years relevant experience.
• Technical writing capability—able to create clear, defensible investigation narratives supported by objective evidence in the eQMS.
• Strong collaboration, prioritization, and communication skills to coordinate cross-functionally and meet complaint closure timelines while maintaining safe lab practices.
• Able to work independently with supervisor support.
• Applies advanced project management skills to oversee device development projects, ensuring timely delivery and compliance.
• Utilizes in-depth knowledge of risk management to evaluate and mitigate potential design risks.
• Experienced in mechanical and electrical engineering, capable of innovating and improving device designs.
• Proficient in design verification, ensuring all products meet the required standards and specifications.
• Understands regulatory compliance, adept at navigating the complexities of medical device regulations.
• Skilled in prototype testing, able to conduct thorough and effective tests to validate device functionality and safety.
• Uses mathematical modeling to assess design feasibility and make necessary adjustments.
• Collaborate effectively with cross-functional teams to achieve project objectives.
• Demonstrates leadership by guiding junior engineers and leading project teams.
• Knowledgeable in Quality Management Systems, applying best practices to ensure product quality.
• Proficient with Computer-Aided Design tools, enhancing design efficiency and accuracy.

Responsibilities

• Lead and manage engineering operations related to medical devices.
• Design, construct, test, and operate equipment to meet quality, cost, safety, reliability, and performance standards.
• Develop design control deliverables to comply with medical device regulations.
• Receive, log, and triage customer complaints and returned devices in accordance with procedures.
• Coordinate laboratory evaluation of returned product and perform root cause analysis.
• Document complaint handling activities in the eQMS and determine outcomes.
• Initiate and support CAPA and nonconformance records.
• Lead project technical workstreams and act as a technical SME in external collaborations.
• Perform design and test activities related to product and manufacturing process.
• Develop design verification protocols and support verification activities.

Skills

Design control

Risk management

Root cause analysis

Project management

Regulatory compliance

Technical writing

Cross-functional collaboration

Leadership

CAD tools

Electrical engineering

Education

Bachelor's degree in Engineering, Chemistry, Biology, or related

Associates degree with 4+ years relevant experience

Tools

CAD software

Job description

Takeda Pharmaceutical Co. 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, safety, and performance standards, while handling customer complaints and supporting CAPA and nonconformance processes. The role requires advanced project management, risk assessment, and collaboration across cross-functional teams.