Engineer IV/Complaint Analysts

Takeda•Lexington, MA

2d•$103,500 - $162,690•Onsite

About The Position

Join Takeda as an Engineer IV, Complaint Analysts. As part of the Engineer IV, Complaint Analysts, you’re adept at solving a range of moderate scope and complexity problems, occasionally referring to policies and practices for guidance. Your work involves analyzing situations and data, exercising judgment within established procedures, and fostering productive relationships internally and externally. You possess solid knowledge of industry practices and contribute to departmental projects and goals, often engaging in frequent internal and external interactions. You may occasionally lead small project teams and provide informal guidance to junior staff, all while working with minimal guidance yourself. Ensure timely complaint handling and investigations of customer reported issues for devices and combination products. About the role: The Engineer IV, Complaint Analysts is responsible for leading and managing engineering operations related to medical devices. This role involves designing, constructing, testing, and operating equipment to ensure quality, cost, safety, reliability, and performance standards are met. By contributing to the development and improvement of medical devices, this role supports Takeda's mission to deliver better health of people worldwide.

Requirements

Associates degree and 4+ years relevant experience or Bachelor’s degree in Engineering, Chemistry, Biology, or related scientific/technical discipline with 2+ years relevant experience.
Experience in a regulated laboratory/quality environment preferred.
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

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 in accordance with applicable procedures and regulatory timelines.
Coordinate and perform laboratory evaluation of returned product (e.g. visual inspection, functional testing), ensuring appropriate biosafety and contamination controls.
Follow investigation plans and execute root cause analysis using structured problem-solving tools and data trending.
Document complaint handling activities end-to-end in the electronic Quality Management System (eQMS), including investigation results, rationale, and conclusions.
Determine complaint outcomes (e.g. confirmed/not confirmed, use error, shipping/handling damage, product malfunction) and support reportability assessments and escalation per procedure.
Initiate and support CAPA and nonconformance records, including containment actions, effectiveness checks, and linkage to complaint investigations.
Identify, collect, and interpret relevant evidence (manufacturing history, risk assessments, nonconformance records, stability/compatibility data where applicable).
Lead project technical workstreams, including planning and execution
Act as a technical SME and liaise with external partners on technical issues
Perform design and test activities related to the product and manufacturing process
Develop statistically sound design verification protocols and support design verification activities
Establish and foster strong collaborative relationships with external partners