Takeda Pharmaceuticals Senior Engineer, Device Testing in Lexington, Massachusetts
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 Engineer, Device Testing where you will be empowered to join a world-class device and combination product development team. You will also plan and implement experiments to guide the development of combination products and medical devices both independently and in collaboration with development team. As part of the Combination Product Device Development team, you will report to Head of Device Design and Test Laboratory.
How you will contribute:
Develop test methods, test method validation protocols, and perform testing at the Device Design and Testing Lab. May help transfer test methods to external laboratories during all stages of combination product development.
Set up, operate, and validate test equipment and perform test method qualification following SOPs.
Support overall test laboratory activities including test development, gage R&R studies, coordination of stability studies/testing, calibration, and preventive maintenance of test equipment.
Provide input to design of fixtures for new experiments, tooling, equipment, and specifications.
Establish and foster collaborative relationships with device and combination product development, quality, external test equipment development / testing partners, and service providers.
Support investigations of out-of-spec test results and deviations.
Participate and interact on project teams.
BS in biomedical engineering, Mechanical Engineering, or related engineering disciplines; at least 5 years of relevant experience in pharmaceutical or medical device industries or Masters with 3 years experience.
Solid background in lab testing of medical devices and combination products (device and drug combinations).
Experience in test method development for medical devices and combination products and validation
Experience working in a regulated lab environment
Advanced degrees in biomedical engineering, Mechanical Engineering, or related engineering disciplines preferred (candidates with advanced degrees and less than 5 years of experience may be considered)
Working knowledge of statistics and related software such as minitab and excel preferred
Knowledge of drug delivery device testing equipment and validation
Knowledge of regulations and standards about medical devices and combination products (ex. Design Control requirements Part 21 CFR 820.30, GxP, Part 11 Electronic Records, etc) preferred
Troubleshoot critical issues and determine causes and possible solutions.
Ability to capture organizational knowledge; improve solutions, processes, and deliverables through use of information.
Ability to manage one's time within the individual, departmental, and corporate goals and timelines; management of internal and external resources (vendors)
Technical – Subject matter knowledge of applicable lab equipment and operations.
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
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.
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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