Staff Device Engineer

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda''s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job DescriptionAt Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Staff Device Engineer where you will support technical efforts for combination products and drug delivery device projects. As a hands-on technical individual and device subject matter expert (SME), you will provide project and engineering leadership in the concept, feasibility, development, qualification and launch phases of device development. You will also focus on identification of user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, process development, DHF creation, and collaboration with both internal stakeholders and external development partners. As part of the Injection Systems team, you will report to Head of Injection Systems and work with Quality, Mfg, Regulatory, R&D, Clinical, Legal, Packaging, and Procurement along with external CROs and CMOs. How you will contribute:Provide technical leadership and contribution on cross functional teams for devices through clinical development, product registration and commercialization. Lead the creation of design control deliverables to comply with medical device and combination device regulations.Establish detailed project plans, define risks and recommend contingency plans.Lead project execution activities and oversee the development of statistically sound design verification protocols/reports and design validation.Establish and foster collaborative relationships with external design/development, manufacturing partners and service providers.Lead or support deviation, complaint and failure investigations.Guide the evaluation of complex drug delivery systems and provide recommendations to move projects forward.Identify and lead device design control process evolution to meet device regulations. Minimum Requirements/Qualifications:Bachelors/Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 6-10 years relevant industry experience orPhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 0+ years relevant industry experienceMore than 5 years experience for BS in the field of combination product or medical device development and commercialization is desired.Experience in parenteral drug delivery devices preferred.Experience in developing and commercializing regulated devices / combination products under Design Control (21 CFR 820) and ISO14791 requirements.Prior technical leadership experience creating design control/technical file deliverables and manufacturing scale-up a plus.Proven track record of developing and gain regulatory approval of drug delivery systems a plusKnowledge of global industry standards (ex: ISO, AAMI, ANSI, etc.).Hands-on leadership with a track record of delivering new products to market.Experience presenting in front of diverse audiences, is desirable.Prior experience leading projects with external design, development, and manufacturing partners.Working knowledge of solid works desirable.FDA regulated devices / combination products under Design Control regulations and ISO 14971.Engineering principles, concepts and applications. What Takeda can offer you:Comprehensive Healthcare: Medical, Dental, and VisionFinancial Planning & Stability: 401(k) with company match and Annual Retirement Contribution PlanHealth & Wellness programs including onsite flu shots and health screeningsGenerous time off for vacation and the option to purchase additional vacation daysCommunity Outreach Programs and company match of charitable contributionsFamily Planning SupportFlexible Work PathsTuition reimbursement 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. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.LI-SB1 EEO StatementTakeda 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.LocationsLexington, MAWorker TypeEmployeeWorker Sub-TypeRegular Time Type Full time

Created: 2026-04-04