Engineer IV/Complaint Analysts
Takeda
August 14, 2026
On-site
Lexington, MA
$103,500 - $162,690 USD yearly
Operations
Join Takeda as an Engineer IV, Complaint Analysts. Ensure timely complaint handling and investigations of customer reported issues for devices and combination products.
How you will contribute
- Support the device technical team in creating design control deliverables to comply with medical device regulations.
- Develop user, product, and system requirements; perform risk management evaluations.
- Receive, log, and triage customer complaints and returned devices/combination products per procedures and regulatory timelines.
- Coordinate and perform laboratory evaluation of returned products (visual inspection, functional testing) with appropriate biosafety/contamination controls; execute root cause analysis using structured problem-solving and data trending.
- Document complaint handling end-to-end in the electronic Quality Management System (eQMS), including investigation results, rationale, and conclusions.
- Determine complaint outcomes and support reportability assessments and escalation per procedure.
- Initiate and support CAPA and nonconformance records, including containment actions and effectiveness checks linked to complaint investigations.
- Identify, collect, and interpret relevant evidence (manufacturing history, risk assessments, nonconformance records, stability/compatibility data where applicable).
- Lead project technical workstreams; act as a technical SME and liaise with external partners.
- Perform design and test activities; develop statistically sound design verification protocols and support design verification.
What you bring to Takeda
- Associate’s degree with 4+ years relevant experience or Bachelor’s degree in Engineering/Chemistry/Biology or related discipline with 2+ years relevant experience; regulated laboratory/quality environment experience preferred.
- Technical writing for clear, defensible investigation narratives in eQMS.
- Collaboration, prioritization, and communication skills; able to work independently with supervisor support.
- Advanced project management; in-depth risk management; mechanical/electrical engineering experience.
- Proficient in design verification, prototype testing, mathematical modeling, and Quality Management Systems.
- Proficient with Computer-Aided Design tools.
Important considerations (lab/manufacturing)
- Controlled environment with protective gowning; remove specified personal items.
- Work in cold/wet environment; multiple shifts/weekends as needed; work around chemicals that may require respiratory protection.
How you will contribute
- Support the device technical team in creating design control deliverables to comply with medical device regulations.
- Develop user, product, and system requirements; perform risk management evaluations.
- Receive, log, and triage customer complaints and returned devices/combination products per procedures and regulatory timelines.
- Coordinate and perform laboratory evaluation of returned products (visual inspection, functional testing) with appropriate biosafety/contamination controls; execute root cause analysis using structured problem-solving and data trending.
- Document complaint handling end-to-end in the electronic Quality Management System (eQMS), including investigation results, rationale, and conclusions.
- Determine complaint outcomes and support reportability assessments and escalation per procedure.
- Initiate and support CAPA and nonconformance records, including containment actions and effectiveness checks linked to complaint investigations.
- Identify, collect, and interpret relevant evidence (manufacturing history, risk assessments, nonconformance records, stability/compatibility data where applicable).
- Lead project technical workstreams; act as a technical SME and liaise with external partners.
- Perform design and test activities; develop statistically sound design verification protocols and support design verification.
What you bring to Takeda
- Associate’s degree with 4+ years relevant experience or Bachelor’s degree in Engineering/Chemistry/Biology or related discipline with 2+ years relevant experience; regulated laboratory/quality environment experience preferred.
- Technical writing for clear, defensible investigation narratives in eQMS.
- Collaboration, prioritization, and communication skills; able to work independently with supervisor support.
- Advanced project management; in-depth risk management; mechanical/electrical engineering experience.
- Proficient in design verification, prototype testing, mathematical modeling, and Quality Management Systems.
- Proficient with Computer-Aided Design tools.
Important considerations (lab/manufacturing)
- Controlled environment with protective gowning; remove specified personal items.
- Work in cold/wet environment; multiple shifts/weekends as needed; work around chemicals that may require respiratory protection.