Takeda · 13 hours ago
Senior Manager, Device Quality Engineering
Lexington, MA
Full-time
Hybrid
Mid, Senior Level
$112K/yr - $192K/yr
6+ years expTakeda is a leading global biopharmaceutical company, and they are seeking a Senior Manager for Device Quality Engineering. This role involves providing technical quality leadership for medical device development, ensuring compliance with regulations, and leading quality improvement initiatives throughout the product lifecycle.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Provide technical quality leadership and support for Takeda’s medical device and combination product development efforts throughout clinical development, design transfer, and commercialization
Actively identify, lead, and drive implementation of Continuous Improvement (CI) projects in line with PSDQ goals, key business outcomes, and strategic plan
Accountable for Device Quality functions in oversight of class 2 and 3 drug delivery devices and combination products or more complex holistic device programs (combination of multiple devices, apps, ancillaries)
Leads risk management and quality planning activities for assigned projects
Collaborate with the cross-functional team to incorporate multiple inputs into the risk documents
Be responsible to identify applicable regulations and standards and to ensure that assigned medical device and combination product development projects are in compliance to 21 CFR Parts 4 and 820, ISO 13485, ISO 14971, and other relevant global regulations and international standards
Partner with Device Quality Assurance, Device Regulatory Affairs and Chemistry Manufacturing Control teams to provide technical quality support for regulatory filings
Develop risk-based sampling strategies for design verification, design validation and inspection testing
Act as subject matter expert for Device Development and Risk Management processes within their core teams
Lead quality improvement initiatives and design improvements within lifecycle management of assigned medical devices or combination products
Be responsible for quality assessment in due diligence activities and for supplier qualification including site readiness confirmation for assigned development projects
Support internal and external audits including readiness as an SME on product design documentation and the design control and risk management SOPs
Up to 10% domestic and international travel required
Up to 60% remote work allowed
Qualification
Required
Master's degree in Engineering, Pharmaceutical Sciences, Life sciences or equivalent technical discipline or related field plus 6 years of related experience
Prior experience must include: support the device product development within a medical device organization
Be responsible for compliance with applicable corporate and divisional policies and procedures
Provide overall quality engineering support for the client's projects associated with medical devices belonging to Class II and Class III
Utilize 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, to provide technical quality leadership and support medical device and combination product development through clinical development, design transfer and commercialization
Perform risk assessment activities and conduct Risk Analysis
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
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