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Job Description

About the role:

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 an Engineer IV – Electromechanical Systems where you will support Takeda’s electromechanical device development efforts for combination products used in clinical studies and for commercial releases. You will also translate user needs to product requirements and specification development, feasibility test development, design verification and validation testing, risk assessments, DHF creation, and general project team technical support. As part of the Device Development team, you will to Head, Electromechanical Systems and work with both internal and external partners.

How you will contribute:

• Provide technical support on cross functional teams for devices through clinical development, product registration and launch-readiness. Conduct feasibility and preliminary design verification testing and create design control deliverables to comply with combination product regulations. – 50%

• Support the project execution in compliance with design control SOP. Own/oversee some technical aspects of the development process and the development of statistically sound design verification protocols/s and design validation. Support in maintaining the design history file and associated project plans. – 20%

• Support the assessment and mitigation of technical risks. Support/lead in failure investigations and root cause analysis. – 20%

• Apply Systems engineering principles in development and support continuous process improvement. – 10%

• Guide the evaluation of complex drug delivery systems and provide sound technical recommendations to move projects forward.

• Identify, communicate and lead device design control process evolution to meet device regulations.

• Collaborate with Quality, Mfg, Regulatory, R&D, Clinical, Legal, Packaging, and Procurement.

• Work with external design, development, and manufacturing partners.

• Work with external partners including testing laboratories, CROs and CMOs.

• May require around 10% of travel.

Minimum Requirements/Qualifications:

• A Bachelor of Science degree in Engineering is required, a Master of Science preferred.

• 3 years experience with Bachelor’s and 5 years experience with a Masters, preferably in the field of combination product or medical device development and commercialization. Experience with wearable (on-body) drug delivery or releasing system is desired.

• Hands on technical support and lab skills for measurement using various instruments required.

• Knowledge in creating design control/technical file deliverables.

• Design for Six Sigma (DFSS) certification is desirable.

• Prior experience supporting projects including managing external design, development, and manufacturing partners.

• International travel required.

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

• Knowledge of engineering principles, concepts and applications.

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

• Knowledge of project management techniques, tools and metrics.

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.

Base Salary Range: $87,500 to $125,000, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

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.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time