Senior Device Design Quality Engineer

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Job Title: Senior Device Design Quality Engineer

Location: Lexington, MA

• The Senior Device Design Quality Engineer (DQE) will provide technical quality leadership and support for Takeda’s medical device and combination product development efforts throughout clinical development, product registration, and commercialization.
• This DQE will support class 2 drug delivery devices and combination products.
• This DQE team member will work collaboratively with internal and external partners, on efforts such as design inputs, quality planning, risk management, design verification and validation testing, design transfer, and design changes.
• This DQE team member will ensure Takeda develops medical devices and combination products in accordance with FDA 21 CFR requirements and international standards (e.g., ISO, AAMI, ANSI) and regulations.

How you will contribute:

• Work cross-functionally to provide product quality requirements and quality standards into design inputs, to develop product specifications, and to conduct design verification and validation activities. Develop risk-based sampling plans for design verification and validation testing. Lead risk management and quality planning activities. Partner with and provide oversight of external design/development and manufacturing partners on development activities. Lead design control gap assessments and remediation as required.
• Partner with QA and CMC teams to provide technical quality support to root cause investigations, change control impact assessments, and risk management activities throughout product lifecycle.
• Ensure compliance to 21 CFR Parts 4 and 820, ISO 13485, ISO 14971, and other relevant international standards.

What you bring to Takeda:

• BS and/or MS in engineering or equivalent technical discipline required, and advanced degree preferred
• 6+ years of device and/or combination product development within a medical device or biotech / pharmaceutical organization required, including minimum of 2 in design quality, required
• Extensive knowledge of both US and International Design Control and Risk Management requirements (specifically 21 CFR Part 820, ISO 13485, ISO 14971), as well as other applicable standards required
• Experience in leading design quality activities required
• Experience with statistical and six sigma methods required, and Green/Black Belt preferred
• Experience with risk management processes and tools required
• Experience with sustaining engineering preferred
• Experience with electromechanical device development preferred
• Experience working with external contract partners for design, development, manufacturing, and/or testing required
• Ability to travel within the US and internationally 10% required

Desired: Advanced Degree preferred; extensive experience in Design Development for combination products and implantable devices

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
• Professional training and development opportunities
• Tuition reimbursement

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

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 posting excludes Colorado applicants.

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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.