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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 the Lead of Device Engineer. As a hands-on technical and device subject matter expert, you will provide project and engineering support within the concept, feasibility, development, qualification, and launch phases of device development.

How you will contribute:

• Support device technical team in the creation of design control deliverables to comply with medical device and combination product regulations. Includes development of user, product, and system requirements, risk management evaluations, verification/validation documentation deliverables, and manufacturing technical outputs

• , lead project technical workstreams, including planning and execution

• Be a technical subject matter expert for responsible activities and provide liaison with external partners on technical issues and discussions

• Perform/support design and test activities related to the product, fixtures and supporting elements related to manufacturing process

• Develop statistically sound design verification protocols/reports and support/perform design validation activities.• Support/perform test method development, validation, and execution

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

• Lead deviation, complaint, and failure investigations

Minimum Requirements/Qualifications:

• At least 3 years' of product development experience in the field of medical device,

• Bachelor of Science Degree in Engineering required

• Experience developing and commercializing regulated devices

• Hands-on technical skills with experience delivering to project milestones including experience presenting in front of diverse audiences

• Prior experience working with external design, development, and manufacturing partners

• Working knowledge of Solidworks and previous experience with CAD/CAM desirable.

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.

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

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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