Engineer IV/Complaint Analysts

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

Job summary

Takeda in Lexington, MA seeks an Engineer IV, Complaint Analysts to lead engineering operations for medical devices, ensuring quality, cost, safety, reliability, and performance. You will design, construct, test, and operate equipment while contributing to product development and Takeda's mission to improve health.

You will manage complaint investigations, lead design verification, and collaborate with cross-functional teams and external partners to ensure regulatory compliance and timely CAPA

Qualifications

• Associates degree with 4+ years relevant experience or a Bachelors in Engineering, Chemistry, Biology, or related technical field with 2+ years relevant experience.
• Experience in a regulated laboratory or quality environment preferred.
• Strong technical writing to document investigations with objective evidence in the eQMS.

Responsibilities

• Lead and manage engineering operations for medical devices, ensuring quality, safety, reliability, and performance standards.
• Develop design control deliverables to comply with medical device regulations and perform risk assessments.
• Receive, log, triage customer complaints and returned devices, perform root cause analysis and document in eQMS.
• Coordinate lab evaluation of returned products and perform analysis using structured problem solving and data trending.
• Lead project workstreams, act as a technical SME, and collaborate with external partners.

Skills

Technical writing

Design verification

Risk management

Regulatory compliance

Project management

Leadership

Cross-functional collaboration

CAD

Troubleshooting

Data analysis

Education

Associates degree +4 years experience or Bachelors in Engineering, Chemistry, Biology or related with 2+ years experience

Tools

CAD tools

Job description

Job Description

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 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:

• 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.

#GMSGQ #ZR1 #LI-MA1

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

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.

For information about our benefits, please click here.

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.