Senior Staff Engineer

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Job Description

At 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 Senior Staff Engineer where you will lead technical efforts for combination products and drug delivery device projects. As a hands-on technical lead/contributor 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, equipment development oversight. You will have collaboration with internal and external partners. As part of the Reconstitution Systems team, you will report to Head, Single Use & Access Devices.

• 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. - 50%

• Establish detailed project plans, define risks and recommend contingency plans. -20%

• Lead project execution activities and oversee the development of statistically sound design verification protocols/reports and design validation. - 20%

• Establish and foster collaborative relationships with external design/development, manufacturing partners and service providers. -5%

• Lead or support deviation, complaint and failure investigations. -5%

• A Bachelor's of Science Degree in Engineering required, a Master's of Science Degree preferred.

• 7-10 years' experience in the field of medical device or combination product development and commercialization is required.

• Prior technical leadership experience creating design control/technical file deliverables and manufacturing scale-up a plus.

• Experience developing and commercializing regulated devices / combination products under Design Control (21 CFR 820) and ISO14791 requirements.

• Experience developing and gain regulatory approval of drug delivery systems a plus.

• Knowledge of global industry standards (ex: ISO, AAMI, ANSI, etc..).

• Hands on technical leadership skills with experience delivering new products to market.

• Experience presenting in front of multidisciplinary audiences, is desirable.

• DFSS certification is desirable.

• Prior experience leading projects with external design, development and manufacturing partners.

• Working knowledge of solid works desirable.

• Knowledge of project management techniques, tools and metrics.

• Mentor technical and cross functional team members.

• Knowledge of developing and commercializing FDA regulated devices / combination products under Design Control regulations and ISO 14971.

• International travel required.

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Flexible Work Paths

• Tuition reimbursement

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.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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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.

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