Senior Manager, Software Device Quality

About the role

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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, wit 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.

Core Competencies

• Technical Expertise: Strong scientific and analytical skills to assess complex data and make risk-based quality decisions
• Leadership: Ability to influence, build relationships, and drive results across global, cross-functional teams
• Decision-Making: Confident decision-making in complex and ambiguous environments, with a focus on continuous improvement
• Collaboration: Proven ability to partner effectively across functions and geographies
• Innovation: Drives process improvements through product and quality insights
• Adaptability: Thrives in dynamic environments and effectively manages complexity and change

Empowering our people to shine

#GSQ

Takeda Compensation and Benefits Summary

• We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
• For Location: Lexington, MA

U.S. Base Salary Range

$137,000.00 - $215,270.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.