Engineer IV/Complaint Analysts

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

Join Takeda as a Engineer IV, Complaint Analyst.

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 to people worldwide.

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, 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

What you bring to Takeda:

• 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

Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body.
• This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Takeda Compensation and Benefits Summary

For Location: Lexington, MA U.S. Base Salary Range: $103,500.00 - $162,690.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations Lexington, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do.

We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

Takeda is an equal opportunity employer.