Senior Staff Engineer

3316 Takeda Development Center Americas • Lexington, MA

9d • Onsite

About The Position

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.

Requirements

• 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.
• 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.
• 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.

Nice To Haves

• PhD is a plus.
• Design for Six Sigma certification is desirable.

Responsibilities

• 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.
• 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.

Benefits

• 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 information about our benefits, please click here.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior