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OBJECTIVES/PURPOSE:
• Lead, mentor, and develop the Injection Systems Development device engineering team to strengthen technical capability, execution discipline, and talent growth.
• Drive consistency in the application and evolution of device platforms, design standards, and Design Control/DHF expectations across programs and partners.
• Assure robust, compliant device/combination product solutions by guiding risk management and verification/validation strategy and driving data-based technical decisions.
• Partner with internal stakeholders and external development/manufacturing partners to align user needs, requirements, and execution plans, ensuring timely delivery of robust platform-based solutions.
ACCOUNTABILITIES:
CORE ELEMENTS RELATED TO THIS ROLE:
• Leads and develops a team of device engineers to provide injection system combination products for subcutaneous drug formulations.
• Provides technical governance and consistency across multiple device/combination programs, rather than driving development for a single asset.
DIMENSIONS AND ASPECTS:
Technical/Functional (Line) Expertise
Leadership
Decision-making and Autonomy
• Makes day-to-day technical and execution decisions across multiple projects (test strategy, requirements maturity, V&V approach, DHF completeness) and escalates high-impact trade-offs as needed.
• Evaluates complex drug delivery system issues and data; provides clear go/no-go recommendations, defines mitigations, and leads/assists investigations to resolve deviations and test failures.
Interaction
• Partners closely with internal stakeholders (Quality, Manufacturing, Regulatory, Drug Product development, Clinical, Legal) to align technical deliverables, timelines, and compliance expectations.
• Establishes and maintains strong working relationships with external design/development and manufacturing partners, service providers, testing laboratories, CROs, and CMOs.
Innovation
• Develops fit-for-purpose feasibility and verification strategies and encourages technically rigorous, data-driven experimentation to retire risk early.
• Builds organizational capability by coaching best practices (e.g., applying In-Silico first principles and DFSS where applicable), codifying lessons learned, and sharing knowledge across programs and with partners.
Complexity
• Manages technical execution across a portfolio of device/combination product programs in parallel, balancing competing priorities, schedules, and resource constraints.
• Operates within a highly regulated, global standards environment (FDA, ISO, AAMI/ANSI) and a complex external partner network, requiring disciplined documentation and alignment across organizations.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
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:
$154,400.00 - $242,550.00
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.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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.
Lexington, MA
Employee
Regular
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.
We strive to transform lives. While the science we advance is constantly evolving, our core purpose is enduring. For more than two centuries, our values have guided us to do what’s right for patients and for society.
We know that changing lives requires us to do things differently. We start by listening to and addressing what really matters to patients, the people who love them, and those in the healthcare system who provide care. And that’s what inspires us all to be bold, push boundaries and set new standards that open up greater opportunities.
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