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Job Description

About the role:

Plasma-derived therapies are critical, life-saving medicines, which patients with rare and complex diseases around the world rely on every day. Global demand for these therapies, particularly immunoglobulins, has increased dramatically over the last 15 years, and continues to grow. Takeda is established as second largest provider of plasma-derived therapies (PDT) globally. Leveraging on 75+ year pioneering legacy, Takeda believes there is tremendous potential to do more to meet expectations of patients and health care providers with plasma-derived therapies for patients with immunologic, hematologic, autoimmune and other complex diseases. As a member of the PDT R&D team based in our Lexington, MA office, you will report to Head, PDT Device Development. You will be responsible for executing and delivering on technical deliverables for medical devices, drug-device combination products, medical technology products and qualification of Medical Devices used in clinical studies.

How you will contribute:

• Lead device technical teams in the creation of design control deliverables to comply with medical device and combination product regulations

• Responsibilities include development of user, product and system requirements, risk management evaluations, design outputs/product specification, verification/validation deliverables

• Maintain overall ownership of all technical deliverables related to product design, performance and risk for assigned projects and lead technical project workstreams including planning and execution.

• Be a technical Subject Matter Expert for product design, performance and risk as it relates to fixtures, drug/device qualification, manufacturing process and packaging/labeling

• Develop statistically sound test protocols/reports and perform design verification activities

• Perform test method development, validation and execution

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

• Be a technical Subject Matter Expert for product design, performance and risk around activities with external development partners/consultants and during manufacturing process development, validation and post-commercial activities

• Contribute to the project management process, identify and define risks to recommend contingency plans

Minimum requirements/qualifications:

• 9 years of experience in the field of medical device or combination product development and commercialization is required

• A Bachelor of Science Degree in Engineering

• Prior experience as a technical leader

• Experience developing and commercializing regulated devices / combination products under Design Control (21 CFR 820), ISO 13485 and ISO14791 requirements.

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

• hands-on technical skills with experience delivering products to market.

• experience presenting in front of multidisciplinary audiences, is required.

• R&D experience creating concepts that generate technical specifications and prototypes.

• Prior experience leading the technical aspects of a project with external design, development and manufacturing partners is required

• Prior experience directing the work of other engineers and mentoring is required

What Takeda can offer you:

• 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

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.

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

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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