Senior Staff Engineer

Takeda; Lexington (MA); On-site; USD 137,000 - 215,000; Full time

Job summary

Takeda in Lexington, MA is seeking a Senior Staff Engineer to lead and manage engineering operations for medical devices. You will design, test, and operate equipment to meet quality, cost, safety, reliability, and performance standards, driving innovation and regulatory compliance.

You will collaborate with cross-functional teams, mentor junior staff, develop protocols, validate methods, and engage with external labs. A strong background in GxP, Design Control, and ISO 13485 is preferred.

Qualifications

• BS or MS in engineering with 8+ years in medical devices/combination products
• Experience with Design Control (21 CFR 820) and ISO 13485
• Strong cross-functional collaboration and problem-solving skills

Responsibilities

• Lead and manage engineering operations for medical devices, ensuring quality, cost, safety, reliability and performance standards.
• Develop protocols, study plans, and technical documentation aligned with regulatory strategies for IND/CTA and NDA/BLA submissions as applicable.
• Author, review, and approve phase-appropriate protocols and reports; ensure data integrity and root-cause investigations when needed.
• Plan and execute advanced mechanical engineering activities: test methods, GR&R, CAD fixtures (SolidWorks), 3D printing, CT data analysis, GxP validation.
• Mentor junior staff and partner with Drug Product Development, Analytical Development, and Quality to drive device qualification, method transfer, and validation.
• Coordinate with CROs/CMOs and external labs to ensure compliant protocols, reports, and data; support investigations and deviations.

Job description

Job Description

Join Takeda as a Senior Staff Engineer.As a Senior Staff Engineer professional within the organization, you develop innovative solutions to complex problems aligned with organizational objectives. Your work involves addressing intricate issues, requiring in-depth analysis and judgment. You also engage with key contacts outside your expertise area and contribute to the development of new concepts and standards. Operating with considerable autonomy, you serve as a consultant to management and an external spokesperson on major matters, often working independently and leading function teams or projects. Additionally, you play a role in training and mentoring junior staff.

About the role:

The Senior Staff Engineer is responsible for leading and managing engineering operations related to medical devices. This role focuses on designing, constructing, testing, and operating equipment to ensure quality, cost, safety, reliability, and performance standards are met. By driving innovation and compliance, this role supports Takeda's mission to deliver transformative therapies to patients.

How you will contribute:

• Maintain protocol templates, writing standards, and technical guidance to promote standardization, reduce cycle time, and improve right-first-time quality across programs.

• Ensure compliance with Quality Management Systems, Good Manufacturing Practices, and applicable regulatory requirements. Author, review, and approve phase-appropriate protocols for device and combination product development and commercialization.

• Develop study protocols and technical documentation aligned with regulatory strategies for combination products, supporting IND/CTA, NDA/BLA/MAA submissions and technical files, as applicable.

• Plan and execute advanced mechanical engineering activities, including test method development and validation, GR&R analysis, CAD based fixture design and fabrication (SolidWorks), 3D printing, CT scan/Volume Graphics data analysis and visualization, test system validation (GxP), and continuous improvement initiatives.

• Conduct technical reviews of study reports and datasets, confirming protocol adherence, data integrity, appropriate investigation of deviations and out-of-specification results, and scientifically sound conclusions.

• Partner with Drug Product Development, Analytical Development, Applied Statistics, Device and Packaging Engineering, and Quality to plan and execute device qualification activities including, test methods/fixture development, validation/transfer, ensuring compliant protocols, reports, and data.

• Manage relationships with external testing laboratories, CROs, and CMOs, supporting method transfer and validation and authoring, reviewing, and approving GxP validation protocols and reports. Additional tasks include continued technical support and root cause investigation.

• Advanced knowledge in injection molding and product design, providing expertise in highly specialized tasks.

• Capable of leading the validation of test methods and equipment, ensuring compliance with medical device regulations.

What you bring to Takeda:

• B.S. degree in the field of engineering (Mechanical Engineering, Chemical Engineering, Materials Science, Biomedical Engineering, Pharmaceutics) and 8+ years relevant industry experience, or M.S. degree and 6+ years relevant industry experience focused on testing of medical devices or combination products. PhD is a plus.

• Experience in developing and commercializing regulated devices/combination products under Design Control (21 CFR 820) and ISO 14791 requirements.

• Proven track record of leveraging existing methods or standards and ability to develop new methods. Knowledge of global industry standards (ex: ISO, AAMI, ANSI, etc.).

• Experience in statistical evaluations.

• Design for Six Sigma certification is desirable.

• Understanding of GMP and GxP requirements.

• Strong mentor and coach; invests time in helping others enhance their skills and perform at a higher level.

• Excellent written and oral communication skills. Effective planning and organizational skills.

• Demonstrated experience developing protocols and/or technical documentation in a regulated environment (GxP and/or ISO 13485).

• Risk-based thinking and scientific judgment to define fit-for-purpose scope, resolve ambiguous data, and document rationale for decisions.

• Proven cross-functional collaboration and influencing skills; able to facilitate alignment across Device/Packaging, Analytical, Clinical, Quality, and Regulatory stakeholders.

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.

#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:

$137,000.00 - $215,270.00

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

YesIt 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.