Senior Manager, Software Device Quality
Takeda
Summary
The Senior Manager, Software Device Quality is a seasoned quality and technical leader responsible for supporting software medical devices and combination products across the full product lifecycle - from design and development through manufacturing, distribution, and post-market support. This role ensures compliance with all applicable quality and regulatory requirements and provides leadership across key quality processes.
Job description
About the role
The Senior Manager, Software Device Quality is a seasoned quality and technical leader responsible for supporting software medical devices and combination products across the full product lifecycle - from design and development through manufacturing, distribution, and post-market support. This role ensures compliance with all applicable quality and regulatory requirements and provides leadership across key quality processes.
How you will contribute
- Partner with product development teams to lead quality activities across design controls, including risk management, design inputs/outputs, verification/validation, and design transfer
- Provide quality oversight and approval for change control activities, including design updates, enhancements, bug fixes, and infrastructure changes
- Maintain Design History Files (DHF) and Technical Files
- Support global regulatory submissions and approvals for software and combination products
- Oversee verification and validation activities to ensure compliance and product quality
- Provide quality ownership and oversight of risk management files (ISO 17971) and Design and Development files (ISO 13485)
- Integrate cybersecurity risk management into the software and device risk management process, including threat modeling, security risk assessments, and SBOM/vulnerability management, in alignment with ISO 14971, AAMI TIR57, and FDA premarket and post market cybersecurity guidance
- Support and contribute to device development process and QMS improvement
- Lead or support regulatory inspections and audits (ISO 13485, and IEC 62304, MDSAP, MDR, and other global requirements)
- Lead investigations into quality events, using root cause analysis, corrective action plans and effectiveness checks
- Monitor product performance through post-market surveillance and drive inspection readiness as well as continuous improvement across QMS
What you bring to Takeda
- Bachelor's degree in biomedical, mechanical, electrical engineering, quality engineering or related technical field
- 7+ years of experience in medical device quality/ Engineering experience within medical devices or pharmaceutical industries
- Working knowledge of quality systems and standards relevant to medical devices (e.g. ISO 13485, and IEC 62304 MDSAP, ISO 14971, MDR/MDD, 21 CFR Part 820)
- Working knowledge of medical device cybersecurity and how it applies to risk management (e.g., security risk assessment, threat modeling, vulnerability management, and post market surveillance)
- Experience with regulatory submissions and commercial product development
- Experience working with external manufacturing partners and driving effective investigations and root cause analysis
- Demonstrated ability to partner seamlessly with cross-functional teams to deliver quality outcomes across the product lifecycle
- Strong cross-functional collaboration and project/program management experience
Preferred
- Advanced degree in engineering or quality related discipline
- Software medical device or Quality IT background
- Collaborative leadership style focused on listening, coaching, team development, and integrating multiple perspectives
- Strong business engagement style, with ability to collaborate effectively with both technical and non-technical stakeholders
- Experience leading discussions and interactions during regulatory inspections
- Adaptable and decisive, with ability to respond effectively to changing business priorities, technologies and regulatory requirements
Requirements
- Bachelor's degree in biomedical, mechanical, electrical engineering, quality engineering or related technical field
- 7+ years of experience in medical device quality/engineering within medical devices or pharmaceutical industries
- Working knowledge of quality systems and standards relevant to medical devices (ISO 13485, IEC 62304, MDSAP, ISO 14971, MDR/MDD, 21 CFR Part 820)
- Working knowledge of medical device cybersecurity and how it applies to risk management (security risk assessment, threat modeling, vulnerability management, post market surveillance)
- Experience with regulatory submissions and commercial product development
- Experience working with external manufacturing partners and driving effective investigations and root cause analysis
- Demonstrated ability to partner seamlessly with cross-functional teams to deliver quality outcomes across the product lifecycle
- Strong cross-functional collaboration and project/program management experience
Benefits
- Base Salary Range $137,000 - $215,270
- Medical, Dental & Vision
- 401(k) Matching
- Paid Time Off
Company overview
Takeda Pharmaceutical Company Limited is a Japanese multinational pharmaceutical company founded in 1781 and incorporated in 1925. As one of the world's top 20 largest pharmaceutical companies by revenue and the third largest in Asia, Takeda specializes in developing and commercializing innovative medicines across several therapeutic areas including oncology, rare diseases, neuroscience, gastroenterology, plasma-derived therapies, and vaccines. With approximately 49,095 employees globally, the company operates research and development centers, manufacturing facilities, and commercial operations across 39 U.S. states and numerous countries worldwide. Takeda maintains dual headquarters in Tokyo and Osaka, Japan, with significant operations in Cambridge, Massachusetts, where it serves as the largest life sciences employer in the state. The company's patient-focused approach is guided by its Takeda-ism values of Integrity, Fairness, Honesty, and Perseverance, emphasizing a commitment to delivering life-transforming treatments while advancing sustainable healthcare solutions. Takeda's extensive portfolio includes both innovative biologics and small molecule drugs, supported by strategic acquisitions and partnerships that have expanded its capabilities in areas such as immuno-oncology and rare disease treatments.