{"id":1006823,"url":"https://alion.io/job/takeda-senior-manager-software-device-quality","title":"Senior Manager, Software Device Quality","company":{"id":5984,"name":"Takeda Pharmaceutical","domain":"takeda.com","url":"https://alion.io/company/takeda","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":89,"open_postings":79,"ghost_share":0,"stale_share":0.392,"repost_share":0.076,"time_to_fill_p50_days":27,"computed_at":"2026-11-14T05:58:10Z"}},"role":"Management","role_family":"Management","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Lexington, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":137000,"max":215270,"currency":"USD","period":"year","gross":null,"usd_annual":215270},"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"Design Controls","optional":false},{"name":"Design History File","optional":false},{"name":"IEC 62304","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"SBOM","optional":false},{"name":"Threat Modeling","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-08-26T00:00:00Z","employer_posted_date":"2026-11-13","last_verified_at":"2026-11-14T16:50:21Z","board_verified":true,"closed_at":null,"days_open":80,"trust":{"level":"ok","repost_count":1,"flags":[],"days_open":80},"description":"By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.\nJob Description\nAbout the role\nThe 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.\nHow you will contribute\nPartner with product development teams to lead quality activities across design controls, including risk management, design inputs/outputs, verification/validation, and design transfer\nProvide quality oversight and approval for change control activities, including design updates, enhancements, bug fixes, and infrastructure changes\nMaintain Design History Files (DHF) and Technical Files\nSupport global regulatory submissions and approvals for software and combination products\nOversee verification and validation activities to ensure compliance and product quality\nProvide quality ownership and oversight of risk management files (ISO 17971) and Design and Development files (ISO 13485)\nIntegrate 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\nSupport and contribute to device development process and QMS improvement\nLead or support regulatory inspections and audits (ISO 13485, and IEC 62304, MDSAP, MDR, and other global requirements)\nLead investigations into quality events, using root cause analysis, corrective action plans and effectiveness checks.\nMonitor product performance through post-market surveillance and drive inspection readiness as well as continuous improvement across QMS\nWhat you bring to Takeda\nBachelor’s degree in biomedical, mechanical, electrical engineering, quality engineering or related technical field\n7+ years of experience in medical device quality/ Engineering experience within medical devices or pharmaceutical industries\nWorking 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)\nWorking 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)\nExperience with regulatory submissions and commercial product development\nExperience working with external manufacturing partners and driving effective investigations and root cause analysis\nDemonstrated ability to partner seamlessly with cross-functional teams to deliver quality outcomes across the product lifecycle\nStrong cross-functional collaboration and project/program management experience\nPreferred:\nAdvanced degree in engineering or quality related discipline. Software medical device or Quality IT background\nCollaborative leadership style focused on listening, coaching, team development, and integrating multiple perspectives\nStrong business engagement style, wit ability to collaborate effectively with both technical and non-technical stakeholders.\nExperience leading discussions and interactions during regulatory inspections.\nAdaptable and decisive, with ability to respond effectively to changing business priorities, technologies and regulatory requirements.\nCore Competencies\nTechnical Expertise: Strong scientific and analytical skills to assess complex data and make risk-based quality decisions\nLeadership: Ability to influence, build relationships, and drive results across global, cross-functional teams\nDecision-Making: Confident decision-making in complex and ambiguous environments, with a focus on continuous improvement\nCollaboration: Proven ability to partner effectively across functions and geographies\nInnovation: Drives process improvements through product and quality insights\nAdaptability: Thrives in dynamic environments and effectively manages complexity and change\nMore about us:\nAt 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.\nCertified 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.\nEmpowering our people to shine:\nTakeda 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.\nTakeda Compensation and Benefits Summary\nWe understand compensation is an important factoras you consider the next step in your career. We are committed to equitablepay for all employees, and we strive to be more transparent with our pay practices.\nFor Location:\nLexington, MAU.S. Base Salary Range:\n$137,000.00 - $215,270.00The 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.\nFor information about our benefits, please click here.\nEEO Statement\nTakeda 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.\nLocations\nLexington, MAWorker Type\nEmployeeWorker Sub-Type\nRegularTime Type\nFull timeJob Exempt\nYesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. 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